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Alcon ARGOS® Optical Biometer with Image Guidance

Overview

The Alcon ARGOS® is a non-contact optical biometer based on Swept Source Optical Coherence Tomography (SS-OCT). The system acquires key ocular biometric measurements and performs calculations used to determine appropriate intraocular lens power and type for cataract surgery.

ARGOS® uses a segmented axial length calculation method and integrates with Image Guidance by Alcon® to transfer preoperative information from the clinic to the operating room.

Manufacturer

ARGOS® is manufactured by MOVU Inc., Santa Clara, California, USA.

In 2019, MOVU and Alcon entered into an agreement to integrate ARGOS® into the Alcon cataract surgery ecosystem. ARGOS® with Image Guidance is distributed and integrated by Alcon.

Availability of software functions, IOL formulas and integration options varies by market and system configuration.

Applications

Cataract surgery and IOL calculation

ARGOS® is intended to acquire ocular measurements and perform calculations used to determine the appropriate IOL power and type for implantation.

The system measures:

• axial length;
• keratometry;
• central corneal thickness;
• anterior chamber depth;
• aqueous depth;
• lens thickness;
• white-to-white corneal diameter;
• pupil size;
• angle kappa coordinates Px and Py.

Depending on installed software and Alcon Vision Planner configuration, available IOL formulas can include Barrett Universal II, Barrett Toric, Barrett True K, SRK/T, Holladay, Haigis and Hoffer Q.

Dense and mature cataracts

Swept Source OCT combined with Enhanced Retina Visualization (ERV) is designed to improve acquisition of the retinal signal through significant media opacity.

In a comparative study of 51 eyes with dense cataracts, axial length acquisition success was:

• ARGOS®: 100%;
• IOLMaster 700: 98.04%;
• Anterion: 94.12%;
• Pentacam AXL: 60.78%.

Three eyes could not initially be measured with ARGOS® in standard mode, but axial length was successfully obtained after ERV mode was used. The 100% figure therefore describes the results of that particular study with ERV used when required and should not be interpreted as a guarantee in every dense cataract.

In an earlier comparative study, ARGOS® successfully obtained axial length in 96% of cases, compared with 79% for an OLCR-based device and 77% for a PCI-based device.

Eyes with long axial length

Segmented axial length measurement can be particularly relevant in unusually short or long eyes because individual ocular media are calculated using their respective refractive indices.

In a study of 126 cataract eyes with axial length greater than 25 mm, both ARGOS® and IOLMaster 700 achieved a 100% acquisition rate.

Within-subject standard deviation for axial length was:

• ARGOS®: 0.01 mm;
• IOLMaster 700: 0.03 mm.

The investigators also noted that measurements from different biometers should not automatically be regarded as interchangeable.

Reference imaging

Reference Image functionality is intended for preoperative and postoperative image capture.

During preoperative measurement, ARGOS® captures a reference image containing the patient's individual iris and limbal landmarks.

In a compatible Image Guidance workflow, the image and surgical plan can be transferred to the operating room for:

• cyclotorsion compensation;
• digital surgical-axis guidance;
• toric IOL alignment;
• real-time procedural navigation.

In VERION® configurations, the reference image can be transferred to a compatible Digital Marker. In the current Alcon ecosystem, ARGOS® image guidance can also integrate with Alcon Vision Suite and NGENUITY®.

Technology and features

Sum-of-Segments axial length calculation

ARGOS® does not calculate total axial length by converting the entire optical path using one average refractive index.

Instead, the system measures individual ocular segments:

• cornea;
• aqueous;
• crystalline lens;
• vitreous.

A specific refractive index is applied to each segment, after which the geometric segment lengths are added to derive total axial length.

This approach accounts for the different optical media within an individual eye and can affect IOL calculations, particularly in eyes with atypical axial length.

Swept Source OCT

ARGOS® uses Swept Source OCT with:

• central wavelength: approximately 1060 nm;
• bandwidth: approximately 20 nm;
• scanning speed: approximately 3000 A-lines per second.

The system acquires two-dimensional OCT data and provides imaging from the cornea to the retina.

Alcon states that the 3000 A-lines/s scanning rate is 1.5 times the 2000 A-lines/s rate used for comparison with IOLMaster 700. Biometric capture time is less than one second and can be as low as approximately 0.6 seconds under applicable conditions.

Enhanced Retina Visualization

Enhanced Retina Visualization is intended for situations in which the retinal signal is insufficient, including significant media opacity.

ERV reconfigures the internal optical system to enhance the retinal signal. Alcon describes an approximately tenfold increase in retinal signal compared with normal mode.

The function is designed to improve the likelihood of successful axial length acquisition but does not guarantee successful measurement in every dense cataract.

Auto-capture

ARGOS® incorporates an Auto-Capture mode.

Once the system detects optimal patient alignment and appropriate acquisition conditions, measurements are captured automatically without an additional operator command.

This helps standardize biometric acquisition and reduces manual steps during the examination.

Alignment and fixation guidance

Angle-to-angle and cornea-to-retina SS-OCT imaging provide real-time guidance during biometric acquisition.

The operator can assess:

• ocular alignment;
• fixation;
• measurement-axis positioning;
• anatomical structures used for biometry.

This provides an additional quality check before the measurements are used for IOL calculation.

Measured parameters

ARGOS® provides measurements including:

• Axial Length (AL);
• Keratometry (K);
• Central Corneal Thickness (CCT);
• Anterior Chamber Depth (ACD);
• Aqueous Depth (AD);
• Lens Thickness (LT);
• White-to-White (WTW);
• Pupil Diameter (PD);
• Angle Kappa coordinates Px and Py.

Measurement repeatability

In a clinical study involving 107 eyes, ARGOS® demonstrated low interset variability for several biometric measurements.

Reported mean interset differences included:

• 0.01 mm for axial length;
• 0.01 mm for central corneal thickness;
• 0.01 mm for aqueous depth and anterior chamber depth;
• 0.03 mm for lens thickness.

These values describe performance under the conditions of the study and should not be interpreted as guaranteed measurement accuracy in every patient.

Integration into the Alcon ecosystem

ARGOS® with Image Guidance supports digital transfer of diagnostic information from the clinic to the operating room.

Depending on system configuration, integration can include:

• Alcon Vision Planner;
• VERION® Digital Marker;
• NGENUITY® 3D Visualization System;
• LenSx® Laser System;
• other compatible components of the Alcon Vision Suite.

The preoperative reference image and surgical plan allow the patient's individual iris and limbal landmarks to be used for digital guidance and cyclotorsion compensation.

Technical specifications

• Type: non-contact optical biometer based on Swept Source OCT.
• OCT acquisition: two-dimensional ocular imaging.
• Central wavelength: approximately 1060 nm.
• Bandwidth: approximately 20 nm.
• Scan speed: approximately 3000 A-lines per second.
• Biometric capture time: less than 1 second, as low as approximately 0.6 seconds under applicable conditions.
• Axial length calculation: Sum-of-Segments using specific refractive indices for individual ocular media.
• Axial length: SS-OCT measurement.
• Keratometry: SS-OCT-enhanced keratometry.
• Measured parameters: AL, K, CCT, ACD, AD, LT, WTW, PD and angle kappa coordinates.
• Enhanced Retina Visualization: available for enhanced retinal signal when standard acquisition is difficult.
• Acquisition mode: automatic when optimal alignment is achieved.
• Reference Image: preoperative and postoperative image capture.
• Examination method: non-contact.
• Integration: Alcon Image Guidance and compatible Alcon Vision Suite components depending on configuration.

Benefits

For the surgeon and clinic

• segmented axial length calculation using individual refractive indices for different ocular media;
• high axial length acquisition rates in dense cataracts reported in comparative studies;
• Enhanced Retina Visualization for difficult retinal signal acquisition;
• biometric data capture in less than one second;
• automatic capture when optimal alignment is achieved;
• multiple biometric parameters acquired within one workflow;
• preoperative reference imaging for digital surgical guidance;
• cyclotorsion compensation with compatible Image Guidance systems;
• digital transfer of measurements and surgical planning data within compatible Alcon systems.

For the patient

• non-contact examination;
• standard optical biometry does not require topical anesthesia;
• biometric data can be acquired in less than one second after appropriate positioning;
• ERV improves the ability to obtain axial length through significant lens opacity;
• digital data transfer reduces the need for repeated manual transcription between the diagnostic clinic and operating room.

Alcon CENTURION® Vision System

Overview

The CENTURION® Vision System is an ophthalmic surgical platform for cataract removal by ultrasonic phacoemulsification.

The platform combines Active Fluidics™ technology for dynamic infusion and target intraocular pressure management, OZil® torsional ultrasound, the ACTIVE SENTRY® handpiece with an integrated pressure sensor and the INTREPID® family of phaco and I/A instruments.

The system is designed to support the principal stages of cataract surgery and can operate within an integrated Alcon digital surgical workflow.

Manufacturer

Alcon.

The CENTURION® Vision System with ACTIVE SENTRY® has FDA 510(k) clearance as a phacofragmentation system.

The system forms part of the Alcon Cataract Refractive Suite. Integration options and available components vary according to system configuration and market.

Applications

Cataract phacoemulsification

CENTURION® is designed for ultrasonic emulsification and aspiration of crystalline lens material during cataract surgery.

The system supports cataracts across a range of densities and enables individual adjustment of:

• ultrasound parameters;
• vacuum;
• aspiration flow;
• target intraocular pressure;
• torsional and longitudinal energy modes.

According to Alcon, the INTREPID® Hybrid Tip has cutting performance suitable for cataract densities up to 3+.

Micro-coaxial cataract surgery

The system supports INTREPID® phaco tips including the INTREPID® BALANCED Tip.

One BALANCED Tip configuration features:

• 0.9 mm tip diameter;
• 45° angle;
• geometry designed to increase torsional amplitude at the distal end while reducing movement around the incision.

The tip is used with compatible INTREPID® irrigation sleeves.

The 0.9 mm measurement refers to tip diameter and should not be interpreted as the surgical incision size. Incision size depends on the tip, sleeve and surgical technique used.

IOL implantation

Following lens removal, the system supports irrigation and aspiration of residual cortical material and preparation of the capsular bag for IOL implantation.

CENTURION® can be used during cataract procedures involving different IOL types, including:

• monofocal;
• toric;
• multifocal;
• EDOF IOLs.

IOL type and power are selected from preoperative diagnostic information and are not determined by the CENTURION® system itself.

Technology and features

Active Fluidics™

Active Fluidics™ is designed to dynamically manage infusion and maintain the surgeon-selected target intraocular pressure.

Rather than controlling infusion pressure solely by adjusting bottle height, the system mechanically compresses the BSS® irrigation solution bag using compression plates.

Pressure applied to the irrigation bag is adjusted in response to changing fluidic conditions during surgery.

This allows the system to:

• establish a target IOP;
• dynamically adjust infusion pressure;
• compensate for flow changes during aspiration;
• support anterior chamber stability across different vacuum settings.

Dual-segment peristaltic pump

CENTURION® uses a dual-segment peristaltic pump with seven rollers.

The dual-segment design produces a smoother aspiration profile.

According to Alcon, compared with the INFINITI® system, this design provides a smoother and faster fluidics response and improved followability of lens fragments toward the aspiration port.

ACTIVE SENTRY®

ACTIVE SENTRY® is a phacoemulsification handpiece incorporating a fluidics pressure sensor.

Locating the sensor within the handpiece enables the system to detect pressure changes close to the eye and communicate them to CENTURION® in real time.

When pressure changes occur, the system coordinates:

• Active Fluidics™;
• QuickValve™;
• fluidics control algorithms.

This allows rapid response to pressure changes following occlusion break.

According to Alcon, ACTIVE SENTRY®:

• reduces post-occlusion surge;
• helps maintain anterior chamber stability;
• compensates for average incision leakage;
• automatically accounts for Patient Eye Level;
• enables surgeons to operate at lower target IOP settings.

Actual surgical pressure settings are selected by the surgeon according to the individual clinical situation.

QuickValve™

QuickValve™ forms part of the fluidics control architecture of CENTURION® with ACTIVE SENTRY®.

During a post-occlusion surge event, the system can rapidly release fluid into the aspiration line to reduce anterior chamber volume loss and support faster recovery toward the target pressure.

OZil® Torsional

OZil® Torsional uses side-to-side torsional ultrasound movement rather than relying only on longitudinal forward-and-back motion.

The torsional mechanism is intended to emulsify lens material while reducing repulsion of nuclear fragments from the phaco tip.

In studies and Alcon materials, the combination of CENTURION®, OZil® Torsional and INTREPID® BALANCED Tip has been associated with:

• efficient lens-material removal;
• reduced fragment repulsion;
• lower Cumulative Dissipated Energy in specified comparisons;
• reduced ultrasound time;
• lower aspiration fluid use in specified comparative studies.

These outcomes depend on cataract density, surgical technique, system settings and the tip being used.

INTREPID® BALANCED Tip

The INTREPID® BALANCED Tip is designed to increase torsional amplitude at the distal end while reducing movement of the shaft around the surgical incision.

This design supports efficient delivery of ultrasonic energy to lens material while limiting mechanical movement and thermal effects at the wound.

In a laboratory study, the BALANCED Tip produced the smallest temperature increase among the compared phaco tips. The maximum increase remained below 11 °C under all conditions tested.

This value represents an experimental laboratory result and should not be interpreted as a guaranteed tissue temperature during clinical surgery.

INTREPID® Hybrid Tip

The INTREPID® Hybrid Tip is based on the BALANCED Tip design and incorporates a rounded distal edge made from high-strength polymer.

According to Alcon, the design is intended to:

• reduce the likelihood of capsular injury following inadvertent contact;
• reduce the likelihood of posterior capsule rupture compared with a conventional metal tip in experimental models;
• facilitate occlusion;
• retain BALANCED Tip fluidics characteristics.

Alcon states that Hybrid Tip cutting performance is suitable for cataract densities up to 3+.

INTREPID® Irrigation Sleeve

INTREPID® irrigation sleeves are designed for use with compatible CENTURION® phaco tips.

The sleeve provides irrigation flow and is designed to reduce movement around the incision.

When used with the BALANCED Tip, the system is designed to limit thermal risk at the surgical wound.

INTREPID® Transformer I/A Handpiece

The INTREPID® Transformer I/A Handpiece is designed for irrigation and aspiration of residual cortical material after phacoemulsification.

Its design enables transition between coaxial and bimanual I/A techniques without changing the primary handpiece.

Polymer aspiration tips are available for work close to the capsular bag.

Integration

CENTURION® can operate within the Alcon Cataract Refractive Suite and compatible Alcon digital surgical workflows.

Depending on configuration, the ecosystem may include:

• ARGOS® Biometer with Image Guidance;
• VERION® Digital Marker;
• LenSx® Laser System;
• ORA SYSTEM®;
• compatible surgical microscopes and visualization systems;
• other Alcon digital components.

Integration enables diagnostic and surgical information to be used across a connected workflow and reduces the need for manual transfer of information between devices.

Technical specifications

• Type: ophthalmic surgical system for cataract phacoemulsification.
• Primary fluidics: Active Fluidics™.
• Infusion principle: mechanical compression of a BSS® solution bag using compression plates.
• Pump: peristaltic.
• Pump design: dual segment.
• Rollers: 7.
• Ultrasound: OZil® Torsional with compatible torsional and longitudinal operating modes.
• Handpiece: ACTIVE SENTRY® with integrated fluidics pressure sensor.
• Additional surge-management technology: QuickValve™.
• Phaco tips: INTREPID® BALANCED Tip and INTREPID® Hybrid Tip.
• BALANCED Tip: configurations include 0.9 mm / 45°.
• Hybrid Tip: rounded polymer distal edge; stated cutting performance for cataracts up to 3+.
• Irrigation: compatible INTREPID® sleeves.
• Irrigation / aspiration: INTREPID® Transformer I/A Handpiece.
• Consumables: compatible CENTURION® FMS / Active FMS and irrigation solutions according to system configuration.
• Control: programmable surgical parameters and footswitch.
• Integration: Alcon Cataract Refractive Suite and compatible Alcon digital systems depending on configuration.

Benefits

For the surgeon and clinic

• dynamic infusion pressure management with Active Fluidics™;
• pressure sensing within the ACTIVE SENTRY® handpiece;
• rapid response to pressure changes after occlusion break;
• QuickValve™ technology for additional post-occlusion surge reduction;
• ability to use lower target IOP settings while supporting anterior chamber stability;
• dual-segment seven-roller peristaltic pump;
• OZil® torsional ultrasound;
• broad INTREPID® phaco tip and I/A instrument portfolio;
• low heat generation with BALANCED Tip in laboratory testing;
• Hybrid Tip with a rounded polymer edge designed to provide additional capsular protection;
• integration with compatible Alcon diagnostic and surgical systems.

For the patient

• phacoemulsification can be performed through a small surgical incision according to the selected technique and instrumentation;
• the system dynamically regulates infusion to maintain the surgeon-selected target IOP;
• ACTIVE SENTRY® and QuickValve™ are designed to reduce anterior chamber volume and pressure fluctuations after occlusion break;
• BALANCED Tip geometry is designed to reduce movement and thermal effects around the incision;
• Hybrid Tip incorporates a rounded polymer edge designed to reduce the likelihood of capsular injury during inadvertent contact.

Alcon CONSTELLATION® Vision System

Overview

The CONSTELLATION® Vision System is a combined ophthalmic microsurgical platform for anterior and posterior segment procedures. It integrates vitrectomy, phacoemulsification, lens-material fragmentation, infusion and intraocular pressure management, endoillumination and other functions used in vitreoretinal surgery.

In applicable configurations, CONSTELLATION® can also be integrated with the 532 nm PUREPOINT® photocoagulation laser and the NGENUITY® 3D Visualization System.

Manufacturer

Alcon.

The CONSTELLATION® Vision System was introduced by Alcon in 2008 as a surgical platform for vitreoretinal procedures. Its capabilities have subsequently expanded through new vitrectomy probes, visualization technologies and surgical-data integration.

According to Alcon's indications for use, the system is intended for:

• anterior segment surgery, including phacoemulsification and cataract removal;
• posterior segment vitreoretinal surgery.

Applications

Vitreoretinal surgery

CONSTELLATION® is used for vitrectomy and other posterior segment surgical procedures.

In clinical practice, vitrectomy may be performed for conditions including:

• retinal tears and detachments;
• vitreous hemorrhage and other vitreous opacities;
• macular holes;
• epiretinal membranes;
• complications of diabetic retinopathy;
• intraocular foreign bodies;
• sequelae of ocular trauma.

The ULTRAVIT® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, tissue dissection and lens removal.

The platform also supports diathermy, fluid and gas management and, in appropriate configurations, laser photocoagulation.

Cataract surgery

CONSTELLATION® supports ultrasonic phacoemulsification with OZil® Torsional technology.

The system can operate in:

• torsional modes;
• longitudinal modes;
• combined modes.

OZil® uses side-to-side ultrasonic tip movement. According to Alcon and published studies, compared with specified longitudinal phacoemulsification modes, torsional ultrasound is associated with reduced fragment repulsion, improved followability and a more favorable thermal profile.

Fragmentation

The CONSTELLATION® Fragmentation Handpiece is designed for ultrasonic fragmentation of lens material during posterior segment surgery.

A 20-gauge fragmentation handpiece is available for the system.

Combined procedures

CONSTELLATION® enables cataract and vitreoretinal surgical stages to be performed using a single surgical platform.

When clinically indicated, phacoemulsification and vitrectomy can therefore be performed during the same surgical session without changing the primary surgical console.

Technology and features

Dual-pneumatic vitrectomy probes

CONSTELLATION® supports modern dual-pneumatic vitrectomy probes. Separate pneumatic lines control cutter movement, allowing the port to be actively opened and closed without relying on a spring-return mechanism.

Maximum cut rates in Core mode include:

• HYPERVIT® Dual Blade Vitrectomy Probe: up to 20,000 cuts per minute;
• Advanced ULTRAVIT® Beveled High Speed Probe: up to 10,000 cuts per minute;
• earlier-generation ULTRAVIT® Vitrectomy Probe: up to 7,500 cuts per minute.

HYPERVIT® incorporates a dual-blade design with a continuously open port. Current HYPERVIT® probes are available in 25+ and 27+ gauge configurations.

Duty Cycle Control

For compatible dual-pneumatic probes, the system allows the surgeon to control port duty cycle independently of the selected vacuum and cut rate.

Three principal settings are available:

• Port Biased Open: the port remains open for most of the cutting cycle;
• 50/50: open and closed periods are approximately equal;
• Port Biased Closed: the port remains closed for most of the cutting cycle.

This provides an additional means of controlling vitreous flow during surgery.

IOP compensation

CONSTELLATION® incorporates Alcon's proprietary non-invasive flow sensing technology and continuously monitors infusion pressure.

According to Alcon, the system allows the surgeon to maintain the selected intraocular pressure to within ±2 mmHg while automatically compensating for changes in infusion pressure.

Simultaneous irrigation and infusion are also supported. When combined with valved cannulas and modern vitrectomy probes, this helps support closed-system intraocular fluidic stability.

OZil® Torsional

OZil® Torsional uses side-to-side ultrasonic movement of the phaco tip.

The technology is designed for lens-material emulsification. According to Alcon, compared with specified longitudinal ultrasound modes, benefits include:

• reduced fragment repulsion;
• improved followability;
• a more favorable thermal profile.

PUREPOINT® 532 nm endolaser

PUREPOINT® is a 532 nm ophthalmic photocoagulation laser.

In an applicable configuration it can be integrated with CONSTELLATION® and controlled through the surgical-system interface.

Features include:

• two laser connection ports;
• voice confirmation of parameter changes;
• connected-accessory recognition;
• control of selected functions through the multifunction footswitch.

Xenon illuminator and ENGAUGE® RFID

CONSTELLATION® uses a xenon light source for intraocular illumination.

Technical documentation specifies a minimum output of 50 lumens through a 20-gauge fiber probe at the 100% setting during the first 200 hours of lamp operation. Light output varies according to the connected fiber type and gauge.

ENGAUGE® RFID automatically recognizes compatible devices connected to the system and assists in applying the appropriate settings, including illumination parameters.

V-LOCITY® Efficiency Components

V-LOCITY® combines features designed to simplify system preparation and surgical workflow.

These include:

• one-button Push Prime;
• an articulating surgical tray arm;
• automatic connected-device recognition through ENGAUGE® RFID;
• color-coded and keyed connections;
• fluid-air exchange and viscous-fluid functions in applicable configurations.

Controls and integration

CONSTELLATION® incorporates a 17-inch articulating touchscreen used as the primary system interface.

Additional controls include:

• multifunction footswitch;
• voice confirmation;
• graphical user interface;
• automatic self-test at system start-up.

CONSTELLATION® integrates with the NGENUITY® 3D Visualization System through DATAFUSION™.

Within the NGENUITY® surgical view, the surgeon can monitor real-time CONSTELLATION® data including:

• intraocular pressure;
• flow rate;
• infusion parameters;
• cut rate;
• laser parameters;
• other surgical information.

Technical specifications

• Type: combined ophthalmic microsurgical system for anterior and posterior segment surgery.
• Vitrectomy: dual-pneumatic drive for compatible probes.
• Maximum HYPERVIT® Dual Blade cut rate: 20,000 cuts per minute.
• Maximum Advanced ULTRAVIT® cut rate: 10,000 cuts per minute.
• Maximum earlier-generation ULTRAVIT® cut rate: 7,500 cuts per minute.
• Surgical instrument gauges: 20, 23, 25+ and 27+ G depending on instrument and procedure.
• HYPERVIT® Dual Blade: 25+ and 27+ G.
• IOP control: non-invasive flow sensing and automatic infusion-pressure compensation, maintaining selected IOP to within ±2 mmHg.
• Phacoemulsification: OZil® Torsional with torsional and longitudinal operating modes.
• Fragmentation: 20-gauge CONSTELLATION® Fragmentation Handpiece.
• Laser: PUREPOINT® 532 nm in applicable configurations.
• Laser connections: two ports.
• Illumination: xenon.
• 20-gauge fiber illumination output: minimum 50 lumens at 100% setting during the first 200 hours of lamp operation according to technical documentation.
• Device recognition: ENGAUGE® RFID.
• Controls: 17-inch articulating touchscreen, multifunction footswitch and voice confirmation.
• Integration: NGENUITY® 3D Visualization System with DATAFUSION™.

Benefits

For the clinician and clinic

• vitrectomy, phacoemulsification, fragmentation, diathermy, infusion management and, in applicable configurations, laser photocoagulation on one platform;
• HYPERVIT® cutting at up to 20,000 cuts per minute;
• automatic infusion-pressure compensation and selected IOP maintenance to within ±2 mmHg;
• duty-cycle control for compatible dual-pneumatic probes;
• automatic connected-device recognition through ENGAUGE® RFID;
• V-LOCITY® functions designed to simplify setup and workflow;
• NGENUITY® integration with surgical parameter display through DATAFUSION™.

For the patient

• cataract and vitreoretinal procedures can be combined within one surgical session when clinically indicated;
• availability of small-gauge instrumentation down to 27+ G;
• automatic infusion-pressure compensation during vitreoretinal surgery;
• high-frequency vitrectomy with HYPERVIT® at up to 20,000 cuts per minute.

Alcon NGENUITY® 3D Visualization System

Overview

The Alcon NGENUITY® is a digital stereoscopic 3D visualization system for heads-up ophthalmic microsurgery.

A stereoscopic digital camera is attached to a compatible surgical microscope and transmits the surgical field to a 55-inch 4K OLED display. The surgeon performs the procedure while viewing the stereoscopic image through passive polarized 3D glasses rather than continuously working through the microscope oculars.

The system is used for both anterior and posterior segment surgery and can be integrated with other components of the Alcon surgical ecosystem.

Manufacturer

Alcon.

NGENUITY® technology was originally developed in collaboration with TrueVision® 3D Surgical in the United States.

Alcon began distributing NGENUITY® under an exclusive agreement with TrueVision in 2016 and acquired 100% of TrueVision Systems, Inc. on December 19, 2018.

NGENUITY® acts as an adjunct to a compatible surgical microscope and provides real-time magnified stereoscopic visualization of the surgical field.

Availability of software functions, Digital Image Guidance and integration capabilities varies by software version, system configuration and market.

Applications

Vitreoretinal surgery

NGENUITY® is used for digital visualization of the posterior segment during vitreoretinal surgery.

Applications can include:

• vitrectomy;
• internal limiting membrane peeling;
• epiretinal membrane removal;
• macular hole surgery;
• retinal detachment surgery;
• surgical management of complications of diabetic retinopathy;
• other retinal and vitreous microsurgical procedures.

Digital image processing enables adjustment of color, contrast and brightness and provides specialized visualization modes for selected tissues and dyes.

Cataract surgery

NGENUITY® provides heads-up visualization during cataract surgery, including:

• capsulorhexis;
• phacoemulsification;
• irrigation and aspiration;
• IOL implantation;
• toric IOL alignment when used with a compatible digital image guidance system.

Current software includes dedicated modes designed to enhance visualization of the capsule and other anterior segment structures.

When integrated with Alcon Digital Image Guidance, diagnostic information and surgical guidance can be displayed on the primary surgical screen.

Minimally invasive glaucoma surgery

NGENUITY® supports anterior chamber visualization during minimally invasive glaucoma surgery.

Current software includes MIGS Mode, designed to digitally enhance contrast of anterior chamber angle structures.

According to Alcon, this mode can provide up to 34% greater local contrast under specified conditions compared with surgical microscopes and digital systems without the corresponding image processing.

This can assist visualization of the trabecular meshwork and positioning of compatible MIGS devices.

Teaching and team collaboration

The large stereoscopic display allows other members of the operating room team to view the same surgical field as the surgeon.

This can support:

• resident and surgeon training;
• assistant coordination;
• demonstration of individual surgical steps;
• recording and postoperative review of procedures.

Compatible passive 3D glasses are used by team members for stereoscopic viewing.

Technology and features

Stereoscopic digital camera

NGENUITY® uses a stereoscopic digital surgical camera.

The current system incorporates:

• two Full HD sensors;
• 1920 × 1080 resolution per sensor;
• 60 frames per second for each eye;
• real-time digital image processing.

The two independent images create a stereoscopic image that provides depth perception across the surgical field.

The camera mounts to a compatible surgical microscope and allows the display to become the surgeon's primary visualization interface.

High-speed digital processing

A high-performance processor handles both video streams in real time.

Digital adjustments include:

• brightness;
• contrast;
• color;
• color temperature;
• magnification;
• parameters of specialized visualization modes.

The system supports personalized settings, video playback and multiple image display options.

55-inch 4K OLED display

NGENUITY® uses a 55-inch OLED surgical display with 4K UHD resolution:

• resolution: 3840 × 2160;
• screen size: 55 inches;
• frame rate: 60 fps for each eye;
• stereoscopic viewing through passive polarized 3D glasses.

Compared with LCD technology, OLED provides greater contrast, a wider color range and improved display of dark image regions.

The display and camera resolutions should be distinguished: the display is 4K, while the stereoscopic camera uses two 1920 × 1080 Full HD sensors.

Depth of field and digital magnification

Digital visualization enables magnification to be modified independently of conventional ocular viewing.

According to Alcon, under specified comparison conditions with analog surgical microscopes, NGENUITY® provides:

• up to 48% greater magnification;
• up to 5 times greater depth of field;
• up to 42% greater depth resolution.

These maximum values were obtained under defined technical conditions, including maximum system magnification, a specified camera aperture and viewing distance, and therefore should not be interpreted as constant values during every procedure.

Extended depth of field can reduce the need for frequent manual refocusing during microsurgical maneuvers.

Surgical illumination level

High camera sensitivity and real-time digital processing can allow lower microscope or endoillumination levels to be used in selected surgical settings.

Alcon reports operation at illumination levels up to four times lower under specified conditions without compromising visual outcomes in the studies referenced by the manufacturer.

Lower illumination may theoretically reduce ocular light exposure, but the actual level is selected by the surgeon according to the procedure, optical system and required visualization.

Use of NGENUITY® should not be interpreted as a guarantee against retinal phototoxicity.

Digital Detection and specialized modes

The current NGENUITY® 1.5 software platform includes dedicated digital image enhancement modes.

Depending on configuration, these include:

• Tissue Detail Mode;
• Capsule Clarity Mode;
• MIGS Mode;
• Blue Boost Mode;
• Performance Green Mode;
• Digital Image Guidance.

Mode settings can be further personalized in real time.

The earlier DATAFUSION™ version introduced in 2018 included four preset imaging profiles, so the number and type of available modes depend on the installed software generation.

DATAFUSION™

DATAFUSION™ enables information exchange between NGENUITY® and compatible Alcon surgical platforms.

When integrated with the CONSTELLATION® Vision System, real-time parameters displayed on the main 3D screen can include:

• intraocular pressure;
• flow rate;
• infusion pressure;
• vitrectomy cut rate;
• laser settings;
• other surgical system parameters.

This allows the surgeon to view the surgical field and key system information on a single display rather than repeatedly looking between separate screens.

Alcon Digital Image Guidance

Current NGENUITY® configurations can support Digital Image Guidance within the Alcon digital ecosystem.

When integrated with the ARGOS® Biometer and compatible software, preoperative information can be transferred to the operating room and used for:

• ocular image registration;
• cyclotorsion compensation;
• digital surgical guidance;
• toric IOL positioning;
• digital support during selected stages of cataract surgery.

Specific functions depend on the installed software version and system configuration.

Recording and image distribution

NGENUITY® supports:

• 2D and 3D video recording;
• video playback;
• simultaneous 2D and 3D streaming to multiple displays;
• Picture-in-Picture;
• split-screen processing;
• recording for teaching and documentation.

Technical specifications

• Type: digital stereoscopic 3D visualization system for ophthalmic microsurgery.
• Operating format: heads-up.
• Intended role: adjunct to a compatible surgical microscope.
• Camera: stereoscopic digital surgical camera.
• Sensors: 2 × Full HD.
• Sensor resolution: 1920 × 1080.
• Camera frame rate: 60 fps per eye.
• Processing: high-speed digital image processor.
• Display technology: OLED.
• Display size: 55 inches.
• Display resolution: 4K UHD, 3840 × 2160.
• Display frame rate: 60 fps per eye.
• 3D viewing: passive polarized glasses.
• Depth of field: up to 5× compared with specified analog microscopes under defined Alcon test conditions.
• Magnification: up to 48% greater compared with specified analog microscopes under defined conditions.
• Depth resolution: up to 42% greater under corresponding comparison conditions.
• Illumination: lower illumination settings can be used; Alcon reports up to 4× lower levels under specified conditions.
• Digital modes: Tissue Detail, Capsule Clarity, MIGS, Blue Boost, Performance Green and others depending on software version.
• Recording: 2D / 3D.
• Playback: real-time and recorded material.
• Additional display options: multiple displays, Picture-in-Picture and split screen.
• Integration: DATAFUSION™, Alcon Digital Image Guidance and compatible Alcon Vision Suite components.

Benefits

For the surgeon and surgical team

• heads-up viewing enables the surgeon to work from the primary display rather than continuously leaning toward microscope oculars;
• the large 3D display provides a shared surgical view for the surgeon and operating room team;
• up to 5× extended depth of field under specified technical conditions can reduce frequent manual refocusing;
• digital magnification can be up to 48% greater in the specified comparison with analog microscopes;
• digital enhancement modes allow color, contrast and detail to be adapted to different stages of surgery;
• DATAFUSION™ displays compatible surgical platform parameters on the primary screen;
• Digital Image Guidance can support an integrated cataract surgery workflow;
• procedures can be recorded in 2D or 3D;
• the shared view supports teaching and collaborative review.

In studies and surveys referenced by Alcon, surgeons using NGENUITY® were substantially more likely to report reduced discomfort or pain, improved posture and improved overall ergonomic comfort compared with conventional ocular-based microscopy.

For the patient

• digital visualization may allow lower surgical illumination to be used while maintaining the visualization required by the surgeon;
• extended depth of field and digital image processing support detailed visualization of small structures;
• integrated digital guidance can make preoperative information available during surgery;
• lower light levels may reduce ocular light exposure, although the required illumination is determined by the surgeon for each individual procedure.

FEMTO Z8 NEO

The FEMTO Z8 NEO is a mobile, multipurpose femtosecond laser platform for ophthalmic surgery. A single system supports refractive surgery, cataract surgery and therapeutic corneal procedures. The platform is based on a low-energy pulse concept and incorporates intraoperative optical coherence tomography (OCT).

Manufacturer

Ziemer Ophthalmic Systems AG, Switzerland.

Ziemer has developed its low-energy approach to femtosecond laser surgery over several generations of systems. The first FEMTO LDV system became commercially available in 2005.

Regulatory status:

• CE marked;
• FDA cleared;
• Availability and regulatory clearance of individual applications may vary by country.

Applications

Refractive surgery

• CLEAR / CLEAR Supra: lenticule extraction for flapless vision correction;
• Z-LASIK / LASIK Supra: corneal flap creation;
• Creation of intrastromal pockets.

Cataract surgery

• Z-CATARACT / CLARIGS: capsulotomy, lens fragmentation, clear corneal incisions and arcuate incisions.

Therapeutic corneal surgery

• Keratoplasty: penetrating and lamellar techniques, including anterior and posterior procedures;
• Tunnel creation for intracorneal ring segments (ICRS).

Technology and features

Low Energy Concept

The handpiece is designed to operate with a short working distance between the laser optics and the eye. This allows the laser beam to be focused into a very small spot while using low pulse energy.

Small overlapping laser spots enable precise tissue separation and minimize tissue bridges. According to the manufacturer, the low-energy approach also reduces the potential for undesirable mechanical effects such as tissue rupture and gas-bubble formation.

Intraoperative OCT

Integrated optical coherence tomography provides visualization of ocular structures during the surgical procedure. The system detects the cornea, iris and crystalline lens and assists the surgeon in planning the position and parameters of laser treatments.

TopView Imaging provides an additional visualization option during the procedure.

SLIM handpiece and patient interface

The SLIM handpiece and SLIM patient interface are designed to facilitate docking across a range of ocular anatomies. The system can also be used in pediatric cataract surgery and in patients with limited orbital access.

Laser Monitoring System

The integrated Laser Monitoring System monitors laser operation and supports consistent performance when the device is used in different operating-room environments during the same day.

Mobility and integration

The FEMTO Z8 NEO is built as a mobile wheeled platform with a braking system. It can be positioned directly beside the operating table and surgical microscope and moved away after completion of the laser step. The patient does not need to be transferred to another surgical table for the laser portion of the procedure.

Additional features include:

• Automatic calibration at every start-up;
• Mobility between operating rooms;
• Plug-and-Play setup;
• Integration with ablation and excimer laser systems from other manufacturers.

Technical specifications

• Type: ophthalmic femtosecond laser.
• Operating principle: photodisruption.
• Wavelength: 1020–1060 nm, near-infrared range.
• Pulse duration: 200–500 fs according to FDA documentation.
• Pulse energy: low-energy technology with operating modes in the nanojoule range.
• Pulse repetition rate: depends on configuration and operating mode [confirm against the technical documentation for the installed system].
• Intraoperative imaging: OCT and TopView Imaging.
• Configuration: mobile wheeled platform.

Benefits

For the surgeon and clinic

• One platform for refractive, cataract and therapeutic corneal surgery;
• Mobile design for use across different operating rooms;
• Automatic calibration at start-up;
• Integrated intraoperative OCT and TopView Imaging;
• Compatibility with ablation lasers from other manufacturers;
• Expandable functionality through software applications.

For the patient

• Low-energy laser pulse technology;
• No need for intraoperative transfer between surgical systems;
• Patient interface designed to accommodate different ocular anatomies;
• Platform can also be used in pediatric cataract surgery and in patients with limited orbital access.

Leica M844 F40 Ophthalmic Surgical Microscope

Overview

The Leica M844 F40 is a premium-class ophthalmic surgical microscope designed for advanced anterior and posterior segment surgery.

The system combines Leica OptiChrome™ high-performance optics, direct halogen illumination, an independent OttoFlex™ red-reflex illumination module and QuadZoom™ technology with four separate optical beam paths.

It is designed for detailed visualization of fine ocular structures and provides simultaneous stereoscopic viewing for the surgeon, assistant and, with appropriate accessories, additional observers.

Manufacturer

Leica Microsystems.

The M844 F40 belongs to the Leica M844 family of ophthalmic surgical microscopes.

The F40 version is a floor-stand configuration incorporating an electromagnetic braking system.

Availability of individual accessories, documentation systems, wide-angle viewing systems and other optional components depends on the configuration of the installed microscope.

Applications

Vitreoretinal surgery

The Leica M844 can be used to visualize posterior segment structures during vitreoretinal procedures. Applications can include:

• vitrectomy;
• epiretinal and internal limiting membrane work;
• macular hole surgery;
• retinal detachment surgery;
• surgical management of diabetic retinopathy complications;
• other vitreous and retinal procedures.

For wide-angle posterior segment visualization, the M844 is compatible with systems such as Leica RUV800, BIOM and EIBOS, depending on configuration.

Compatible image inverters can also be integrated, with selected vitreoretinal accessories controlled through the footswitch.

Cataract surgery

The M844 provides magnification, illumination and red-reflex visualization during the principal stages of cataract surgery, including:

• capsulorhexis;
• phacoemulsification;
• irrigation and aspiration;
• IOL implantation;
• IOL positioning.

The independent OttoFlex™ illumination system is designed to enhance the red reflex and image contrast.

An optional Leica ToricEyePiece can support toric IOL orientation.

IOL selection and the specific alignment technique remain determined by the surgeon and the surgical workflow being used.

Corneal surgery

The microscope can be used for visualization of the cornea and anterior chamber during microsurgical procedures including:

• penetrating keratoplasty;
• lamellar keratoplasty;
• DALK;
• DMEK;
• DSAEK;
• management of corneal trauma;
• pterygium removal;
• other anterior segment procedures.

Apochromatically corrected optics support visualization of fine structures with natural color differentiation.

Glaucoma surgery

The Leica M844 can provide magnification and illumination during glaucoma surgery. Applications can include:

• filtration surgery;
• drainage-device implantation;
• selected minimally invasive procedures;
• other anterior segment interventions.

The microscope is a surgical visualization system and does not determine the particular glaucoma treatment selected.

Pediatric ophthalmic surgery

Adjustable magnification, focus, illumination and ergonomic configuration allow the M844 to be used for pediatric ophthalmic microsurgery when clinically appropriate.

The procedure and accessories used depend on the specific surgical requirement.

Teaching and team collaboration

QuadZoom™ provides separate optical beam paths for the surgeon and assistant.

This is particularly useful in teaching environments because the surgeon and assistant can simultaneously view the operative field stereoscopically at the same magnification.

An optional Double Wing attachment can provide full stereo viewing for two assistants.

The system also supports camera and recording solutions for teaching and surgical documentation.

Technology and features

OptiChrome™ optics

The Leica M844 incorporates OptiChrome™ high-performance optics. The optical system is designed to provide:

• high contrast;
• crisp visualization of fine structures;
• high resolution;
• natural color rendition;
• efficient light transmission.

High optical transmission enables detailed visualization at comparatively low illumination settings when sufficient for the particular surgical step.

Actual illumination intensity is selected by the surgeon according to the clinical situation.

Direct halogen illumination

The M844 uses direct halogen illumination.

Rather than relying on a long fiber-optic path for the main illumination, the system delivers focused light through the microscope optics.

Leica describes its two-bulb, two-prism design as a stereoscopic illumination concept intended to provide homogeneous surgical-field illumination and preserve depth perception.

The main illumination uses 12 V / 50 W halogen lamps.

A quick-change lamp mount with two lamps is provided for the main illumination, allowing the system to be switched to the reserve lamp if required.

OttoFlex™

OttoFlex™ is an illumination module independent of the main light and is designed to enhance the red reflex. The system is intended to:

• enhance the red reflex;
• reduce stray light through the sclera;
• increase image contrast.

The OttoFlex™ illumination field can be adjusted from approximately 4 to 35 mm at a 200 mm working distance.

The OttoFlex™ light source also uses a 12 V / 50 W halogen lamp.

Earlier Leica documentation referred to the technology as OttoFlex™ II.

QuadZoom™

QuadZoom™ is a defining feature of the M844. The zoom system incorporates four separate optical beam paths:

• two for the primary surgeon;
• two for the assistant.

This provides full stereoscopic imaging for both observers.

According to Leica:

• surgeon and assistant receive the same magnification;
• the assistant view does not require manual magnification adjustment by the surgeon;
• the assistant can fine-tune focus independently;
• the surgeon retains the full available light in the primary optical path even when a video camera is attached.

The motorized zoom ratio is 6:1.

Assistant viewing system

A 0° stereo assistant attachment is available for the M844. It provides:

• full stereoscopic viewing;
• the same magnification as the surgeon;
• integrated fine focus;
• binocular-tube rotation;
• a documentation port.

An optional Double Wing attachment enables simultaneous stereoscopic viewing by two assistants.

Focus and positioning

The motorized focusing system provides a 54 mm range with automatic reset.

The XY unit is:

• motorized;
• adjustable over 50 × 50 mm;
• equipped with automatic reset.

The microscope tilt drive is motorized over approximately +15° to –50°.

Working distances

OptiChrome™ objectives are available with different working distances:

• WD 175 mm, focal length f = 200 mm;
• WD 200 mm, f = 225 mm;
• WD 225 mm, f = 250 mm.

Objective selection affects working distance, total magnification and field of view.

Magnification

The motorized QuadZoom™ system has a 6:1 zoom range. Total system magnification depends on:

• the binocular tube;
• eyepiece;
• objective;
• working distance.

For example, the current Leica manual specifies approximately 4.1×–24.5× total magnification with an UltraLow™ III binocular tube, 10× eyepieces and the WD 175 mm objective. Other optical configurations provide different magnification ranges.

Binocular tubes and eyepieces

Depending on configuration, ergonomic binocular options include:

• UltraLow™ III;
• variable 0–180°;
• variable 30–150°;
• other compatible tubes.

Wide-field eyepieces for spectacle wearers are available in:

• 8.33×;
• 10×;
• 12.5×.

Diopter adjustment of approximately ±5 D and adjustable eyecups are provided.

F40 floor stand

The Leica F40 is a floor-mounted surgical stand. Key characteristics include:

• four electromagnetic brakes;
• gas-spring balancing;
• maximum reach of approximately 1,492 mm;
• vertical stroke of approximately 846 mm;
• motorized XY unit;
• motorized microscope tilt.

A fully configured F40 system can weigh approximately 330 kg depending on installed equipment.

Touchscreen control

The M844 incorporates a touchscreen user interface. It enables users to:

• select surgeon profiles;
• modify individual settings;
• save parameters;
• load stored configurations;
• control illumination;
• control motorized functions.

Individual starting configurations can be stored for different surgeons.

StepCycle™

StepCycle™ allows a sequence of microscope settings to be programmed for different stages of an operation. Up to 10 steps can be stored within a cycle. The next stored configuration can be activated through an assigned control, such as the footswitch.

This enables predetermined changes in magnification, illumination and other microscope functions as the procedure progresses.

Auto Reset

Auto Reset returns motorized microscope functions to predefined starting settings. It can be used at the completion of a procedure or when preparing for the next case to help standardize system setup.

Foot control

The M844 supports programmable footswitches. Depending on configuration, 12- and 14-function options are available, including wireless configurations. Foot-controlled functions can include:

• magnification;
• focus;
• XY positioning;
• illumination;
• StepCycle™;
• vitreoretinal modes;
• compatible accessories.

Filters

The system incorporates:

• an IR protection filter;
• a UV protection filter, GG420.

Additional filters and accessories may be available depending on the system version.

Documentation

The M844 supports digital photography and video documentation. Current Leica documentation lists compatibility with:

• Leica HD C100 medical camera;
• Manual Video Adapter;
• Remote Video Adapter;
• Zoom Video Adapter;
• external recording systems.

HD C100 provides Full HD display and recording. For more comprehensive documentation, the M844 is also compatible with the EVO 4K recording and documentation system from Med X Change. The exact video configuration depends on the installed equipment.

Technical specifications

• Type: ophthalmic surgical microscope.
• Optics: Leica OptiChrome™, apochromatically corrected.
• Zoom system: QuadZoom™.
• QuadZoom™ beam paths: 4.
• Zoom: motorized, 6:1.
• Total magnification: configuration dependent. Example with UltraLow™ III, 10× eyepieces and WD 175 mm: approximately 4.1×–24.5×.
• Optical field diameter: approximately 7–80 mm.
• Working distances: 175, 200 and 225 mm.
• Objectives: OptiChrome™ f = 200, 225 and 250 mm respectively.
• Focus: motorized. Focus range: 54 mm.
• Automatic focus reset: available.
• Eyepieces: 8.33× / 10× / 12.5×.
• Diopter adjustment: approximately ±5 D.
• Main illumination: direct halogen. Lamps: 12 V / 50 W.
• Red-reflex illumination: independent OttoFlex™ module. OttoFlex™ field diameter: approximately 4–35 mm at WD 200 mm.
• Filters: integrated IR and UV GG420 protection.
• XY positioning: motorized, 50 × 50 mm.
• Tilt: motorized, approximately +15° / –50°.
• Stand: Leica F40 floor stand.
• F40 brakes: 4 electromagnetic brakes.
• Maximum F40 reach: approximately 1,492 mm.
• F40 vertical stroke: approximately 846 mm.
• Microscope weight with accessories and XY unit: approximately 28.3 kg.
• Fully configured F40 system weight: approximately 330 kg at maximum load.
• Controls: touchscreen interface and programmable footswitch.
• Workflow features: StepCycle™, Auto Reset.
• Assistant system: 0° Stereo Assistant Attachment.
• Optional: Double Wing.
• Wide-angle viewing systems: RUV800, BIOM and EIBOS depending on configuration.
• Toric IOL orientation: optional Leica ToricEyePiece.
• Documentation: Leica HD C100 and other compatible systems depending on configuration.
• F40 power supply: 100–240 V AC, 50/60 Hz.
• M844 F40 power consumption: up to 550 VA.

Benefits

For the surgeon and surgical team

• OptiChrome™ optics provide high-contrast visualization and natural color rendition;
• high light transmission supports detailed visualization at comparatively low illumination settings;
• independent OttoFlex™ illumination enhances the red reflex;
• QuadZoom™ provides separate stereoscopic optical paths for surgeon and assistant;
• the assistant receives the same magnification and can adjust fine focus independently;
• the optional Double Wing provides stereoscopic visualization for two assistants;
• according to Leica, attaching a video camera does not divert light from the surgeon's primary optical path;
• motorized zoom, focusing, XY positioning and tilt;
• individualized surgeon profiles;
• StepCycle™ for sequential parameter changes during a procedure;
• Auto Reset for return to the starting configuration;
• compatibility with wide-angle vitreoretinal viewing systems;
• HD and 4K documentation options with compatible equipment.

For the patient

• high optical transmission allows the surgeon to use the minimum illumination sufficient for visualization during each surgical step;
• independent adjustment of main illumination and OttoFlex™ allows light to be adapted to the surgical task;
• integrated UV and IR filters limit the corresponding components of the illumination spectrum;
• high image detail and contrast support visualization of fine ocular structures during microsurgical maneuvers.

OCULUS Corvis® ST Tonometer and Corneal Biomechanics Analyzer

Overview

The OCULUS Corvis® ST is a non-contact tonometer and pachymeter equipped with a high-speed Scheimpflug camera for dynamic assessment of the corneal response to a defined air pulse.

During measurement, the system records the corneal deformation process and uses these data to determine intraocular pressure, biomechanically corrected intraocular pressure (bIOP), corneal thickness and dynamic corneal response parameters.

Depending on the installed software configuration, Corvis® ST also provides tools for biomechanical ectasia screening, post-laser and post-crosslinking follow-up and additional biomechanical assessment in glaucoma.

Manufacturer

OCULUS Optikgeräte GmbH, Wetzlar, Germany.

The OCULUS quality management system is certified according to ISO 13485 and Regulation (EU) 2017/745 on medical devices.

Availability of individual software modules and functions varies by system configuration and market.

Applications

Keratoconus and ectasia screening

Corvis® ST records the dynamic response of the cornea to an air pulse and calculates parameters describing its deformation behavior.

With the optional Dynamic Corneal Response software, the Corvis Biomechanical Index (CBI) can be calculated. It combines several biomechanical parameters and helps identify corneas with an atypical biomechanical profile.

The system can be used:

• in patients with suspected keratoconus;
• for ectasia risk assessment before refractive surgery;
• for longitudinal assessment of corneal biomechanical changes;
• as an adjunct to corneal topography and tomography.

Corvis® ST should not be used in isolation to establish a diagnosis of keratoconus. Its results are interpreted together with clinical examination, topography and corneal tomography.

Preoperative assessment before refractive surgery

Corvis® ST biomechanical parameters can provide additional information when assessing candidates for laser vision correction, including:

• LASIK;
• FemtoLASIK;
• PRK and TransPRK;
• SMILE and other lenticule-based procedures.

When Corvis® ST is combined with Pentacam®, the Tomographic Biomechanical Index (TBI) integrates biomechanical and tomographic information.

TBI uses an artificial intelligence algorithm for combined ectasia risk assessment. A compatible software configuration and Pentacam® data are required for TBI calculation.

Glaucoma assessment

Corvis® ST measures intraocular pressure and calculates biomechanically corrected IOP (bIOP).

The bIOP calculation incorporates:

• corneal thickness;
• age;
• biomechanical corneal response.

The resulting bIOP value is less dependent on corneal biomechanical properties and thickness than conventional non-contact IOP measurements.

Depending on configuration, optional Glaucoma Screening Software with the Biomechanical Glaucoma Factor (BGF) may also be available. BGF was developed as an additional biomechanical risk indicator for normal-tension glaucoma.

Corvis® ST does not replace other clinically required tonometry, visual field testing, optic nerve OCT or optic nerve head assessment.

Follow-up after laser vision correction and corneal crosslinking

Optional software allows longitudinal comparison of corneal biomechanical parameters.

CBI-LVC is designed to assess biomechanical stability after laser vision correction.

The BEST Display can:

• compare examinations against a baseline;
• analyze changes in biomechanical parameters;
• display stress-strain curves;
• superimpose deformation videos;
• evaluate changes after corneal crosslinking;
• provide biomechanical keratoconus staging.

According to OCULUS, changes in selected biomechanical parameters following crosslinking can be measurable within several weeks after treatment.

Technology and features

High-speed Scheimpflug camera

Corvis® ST incorporates a high-speed Scheimpflug camera operating at 4,330 images per second.

During one measurement, the system records:

• 140 images;
• within 31 ms after onset of the air pulse;
• across an 8.5 mm horizontal corneal section.

The sequence generates a short video of corneal deformation. The light source is a UV-free 470 nm blue LED.

Air pulse

During measurement, the cornea is exposed to a controlled air pulse.

The instrument automatically tracks eye position and initiates measurement once the required alignment and focus have been achieved.

This approach standardizes acquisition conditions and reduces operator influence on the measurement process.

Complete deformation cycle

The high-speed camera records the principal stages of the corneal response:

• natural convex shape;
• first applanation;
• inward movement;
• highest concavity;
• outward movement;
• second applanation;
• return toward the natural shape.

The image sequence is analyzed to derive Dynamic Corneal Response parameters describing the speed, magnitude and geometry of deformation.

Biomechanically corrected IOP (bIOP)

bIOP is calculated with consideration of corneal biomechanical response, corneal thickness and patient age.

Unlike measurement methods that depend on light reflection from the tear film, the Scheimpflug imaging principle used by Corvis® ST does not depend on tear-film reflection.

Together with automatic tracking and auto release, this supports highly repeatable IOP and corneal thickness measurements.

Dynamic Corneal Response

Optional Dynamic Corneal Response software performs extended analysis of the Scheimpflug image sequence acquired during the air pulse.

Depending on the software version, available parameters and tools include:

• first and second applanation parameters;
• highest-concavity parameters;
• Deformation Amplitude Ratio;
• Integrated Radius;
• Stiffness Parameter at First Applanation (SP-A1);
• Ambrósio Relational Thickness;
• Stress-Strain Index (SSI);
• Corvis Biomechanical Index (CBI);
• CBI-LVC;
• BEST Display;
• Tomographic Biomechanical Index (TBI) when integrated with Pentacam®.

Corvis Biomechanical Index (CBI)

CBI is calculated from a combination of dynamic corneal response parameters.

The Vinciguerra Screening Report compares the patient's values with normative information and assists the clinician in identifying an atypical biomechanical corneal profile.

The index ranges from 0 to 1, with higher values associated with a biomechanical profile more characteristic of ectatic corneas. CBI is a screening parameter and should be interpreted together with other diagnostic findings.

Tomographic Biomechanical Index (TBI)

TBI combines:

• Pentacam® tomographic information;
• Corvis® ST biomechanical measurements.

The index is calculated using an artificial intelligence algorithm.

Combining geometry and biomechanics provides a more comprehensive approach to ectasia risk assessment and preoperative screening.

Automatic TBI calculation requires Corvis® ST and Pentacam® to be connected within a compatible software environment, together with the appropriate Pentacam® software license.

Pachymetry

Corvis® ST measures corneal thickness during the same examination as tonometry.

Key parameters include:

• pachymetry range of 300–1,200 µm;
• 8.5 mm horizontal measurement coverage;
• 576 measurement points per image.

The software can display current corneal thickness measurements and pachymetric changes over time.

Automatic tracking and quality control

The system includes:

• 3D auto tracking;
• automatic measurement release;
• integrated measurement quality assessment.

Automation helps standardize eye position and the timing of the air pulse, reducing dependence on operator technique.

Patient communication

In selected software configurations, IOP and corneal thickness values together with the deformation video can be prepared for transmission to the patient by email.

The feature is primarily intended to support clear explanation of examination findings.

Technical specifications

• Type: non-contact tonometer and pachymeter with high-speed Scheimpflug camera.
• Measurement principle: dynamic recording of corneal deformation following a controlled air pulse.
• IOP measurement range: 6–60 mmHg.
• Measurement distance: 11 mm.
• Internal fixation light: red LED.
• Positioning: 3D auto tracking.
• Measurement release: automatic.
• Scheimpflug camera frame rate: 4,330 images per second.
• Single measurement recording: 140 images within 31 ms.
• Horizontal measurement coverage: 8.5 mm.
• Pachymeter range: 300–1,200 µm.
• Measuring points: 576 per image.
• Light source: 470 nm blue LED, UV-free.
• Standard outputs: IOP, bIOP, corneal thickness, pachymetric progression and biomechanical response video.
• Dynamic Corneal Response software: optional.
• CBI, TBI, CBI-LVC, BEST Display and SSI: available with applicable software configurations.
• TBI: requires integration with Pentacam® tomographic data.
• Dimensions (W × D × H): 266 × 538 × 495–525 mm.
• Weight: approximately 14 kg.
• Maximum power consumption: 26 W.
• Power supply: 100–240 V AC, 50–60 Hz.

Benefits

For the clinician and clinic

• non-contact tonometry, pachymetry and dynamic corneal imaging within one system;
• 4,330 images per second for analysis of the full deformation cycle;
• bIOP incorporating corneal biomechanics, corneal thickness and age;
• Scheimpflug measurement does not depend on tear-film reflection;
• automatic 3D tracking and auto release;
• CBI for biomechanical corneal screening;
• TBI for combined tomographic and biomechanical assessment when integrated with Pentacam®;
• CBI-LVC and BEST Display for longitudinal assessment following laser vision correction and crosslinking;
• additional biomechanical information that can contribute to glaucoma assessment.

For the patient

• non-contact examination;
• no topical anesthetic drops are required;
• the dynamic deformation recording itself takes 31 ms;
• one examination provides information about IOP, corneal thickness and biomechanical response;
• deformation video can be used to explain the examination visually.

Pentacam® and Pentacam® HR

The Pentacam® and Pentacam® HR are non-contact anterior segment tomography systems based on a rotating Scheimpflug camera. During a single scan, the system acquires a series of optical cross-sectional images and generates a three-dimensional model of the anterior eye segment from the anterior corneal surface to the posterior surface of the crystalline lens.

The examination provides data on the anterior and posterior corneal surfaces, corneal thickness and refractive power, as well as parameters of the anterior chamber. The Pentacam® HR provides higher-resolution imaging and a greater density of measurement data.

Manufacturer

OCULUS Optikgeräte GmbH, Wetzlar, Germany.

The OCULUS quality management system is certified:

• according to ISO 13485;
• in accordance with Regulation (EU) 2017/745 on medical devices (MDR).

Availability of individual software modules and functions depends on the model, year of manufacture, installed software and country of use.

Applications

Refractive surgery

The Pentacam® is used for comprehensive corneal assessment before refractive surgery. Tomography of the anterior and posterior corneal surfaces, pachymetry and analysis of corneal thickness progression support the detection of signs associated with keratoconus and other ectatic disorders and help assess the cornea before LASIK, PRK, SMILE and other procedures.

The system is also used for:

• preoperative planning of corneal refractive surgery;
• planning of intracorneal ring implantation;
• comparison of examinations and documentation of corneal changes following surgery.

Cataract surgery

The Pentacam® provides information on total corneal refractive power, including data from the posterior corneal surface, for cataract surgery planning and IOL selection.

The Cataract Pre-OP Display assists in assessing corneal parameters when considering standard, toric, aspheric and multifocal IOLs.

Additional options include:

• IOL Calculator for treated and untreated eyes;
• Holladay Report and Holladay EKR Detail Report for assessing corneal refractive power after refractive surgery;
• PNS and 3D Cataract Analysis for quantitative assessment of lens opacities;
• Total Corneal Refractive Power (TCRP), calculated using ray tracing.

The Pentacam® and Pentacam® HR do not measure axial length. When the optional IOL Calculator is used, axial length must be entered separately or obtained from another biometric device.

Screening and assessment of corneal pathology

The Belin/Ambrósio Enhanced Ectasia Display combines anterior and posterior corneal elevation data with analysis of corneal thickness distribution and progression. It is used to identify tomographic patterns associated with keratoconus and other ectatic disorders and to support risk assessment before refractive surgery.

Scheimpflug imaging can also be used to visualize and assess corneal changes associated with conditions including:

• keratoconus;
• pellucid marginal degeneration;
• Fuchs' dystrophy;
• pterygium;
• corneal scars and other structural abnormalities.

The Belin/Ambrósio Enhanced Ectasia Display was developed with the involvement of Prof. Michael W. Belin and Renato Ambrósio Jr.

Anterior chamber assessment in glaucoma screening

The Pentacam® automatically determines anterior chamber parameters including:

• anterior chamber angle;
• anterior chamber depth;
• anterior chamber volume;
• corneal thickness.

These measurements can form part of a comprehensive assessment of patients at risk of angle closure. The software also includes various correction tables and formulas for adjusting measured intraocular pressure according to corneal thickness.

The Pentacam® does not replace tonometry, perimetry, optic nerve assessment or other components of a complete glaucoma evaluation.

Contact lens fitting

Optional Pentacam® software assists with fitting rigid gas-permeable, orthokeratology and other contact lenses using the shape of the measured corneal surface.

Functions include:

• automatic lens suggestions;
• manual modification of lens parameters;
• simulated fluorescein patterns;
• assessment of lens position relative to the corneal surface;
• an integrated contact lens geometry database.

Current Pentacam® HR configurations can also provide extended functionality for scleral lens fitting, depending on the device configuration and installed software.

Technology and features

Rotating Scheimpflug camera

During measurement, the camera rotates around the optical axis and captures sequential images of the anterior eye segment from different angles.

The software uses these data to generate a three-dimensional model and calculate parameters for the anterior and posterior corneal surfaces.

Unlike Placido-based topography, Scheimpflug technology derives elevation information directly from optical cross-sectional images. Central data are measured rather than extrapolated, and the measurement does not depend on reflection from the tear film.

The main differences between the two models are:

• Pentacam®: up to 50 images in 2 seconds and up to 25,000 evaluated elevation points;
• Pentacam® HR: up to 100 images in 2 seconds in Cornea Fine Scan mode and up to 138,000 evaluated elevation points.

Blue LED illumination

The system uses blue LEDs with a wavelength of 475 nm and no ultraviolet radiation.

Scheimpflug imaging detects light scattering within anterior segment structures, allowing images of the cornea and crystalline lens to be obtained and optical density to be assessed quantitatively when the appropriate software modules are installed.

Iris camera

A secondary camera is used to monitor eye position during the scan.

The software determines:

• pupil position and shape;
• horizontal white-to-white corneal diameter (HWTW);
• eye movements during acquisition.

Detected eye movements are taken into account during calculation of the three-dimensional anterior chamber model.

Fast Screening Report

After image acquisition, the system performs a measurement quality check and summarizes key parameters in a consolidated report.

The Fast Screening Report compares examination data with normative values and helps the clinician identify parameters requiring closer assessment.

The normative data are based on published clinical studies, and references to the relevant literature can be accessed from within the software.

Additional modules

Depending on the model and purchased licenses, available modules may include:

• Belin/Ambrósio Enhanced Ectasia Display;
• Belin ABCD Keratoconus Staging and Progression Display;
• Holladay Report and Holladay EKR Detail Report;
• IOL Calculator;
• Cataract Pre-OP Display;
• PNS and 3D Cataract Analysis;
• Corneal Optical Densitometry;
• Corneal Rings;
• corneal aberrometry;
• 3D pIOL Simulation and Aging Prediction;
• contact lens fitting software;
• DICOM.

The 3D pIOL Simulation and Aging Prediction module supports preoperative planning of iris-fixated phakic IOLs. Availability depends on the specific Pentacam® model and software configuration.

Integration

The optional DICOM module enables the Pentacam® to be incorporated into the digital infrastructure of a medical facility.

Depending on configuration, the system can:

• receive patient information through DICOM Worklist;
• transfer examination results to PACS;
• provide access to examination data from multiple workstations using the appropriate network licensing.

Technical specifications

Pentacam®

• Type: non-contact tomography system with rotating Scheimpflug camera.
• Camera: digital CCD.
• Light source: blue LEDs, 475 nm, UV-free.
• Processor: DSP, 400 million operations per second.
• Speed: up to 50 images in 2 seconds.
• Evaluated elevation points: up to 25,000.
• Curvature range: 3–38 mm / 9–99 D.
• Precision: ±0.2 D.
• Reproducibility: ±0.2 D.
• Operating distance: 80 mm.
• Dimensions (W × D × H): 275 × 320–400 × 500–530 mm.
• Measuring head weight: 7.2 kg.
• Maximum power draw: 35 W.

Pentacam® HR

• Type: non-contact high-resolution tomography system with rotating Scheimpflug camera.
• Camera: digital CMOS.
• Light source: blue LEDs, 475 nm, UV-free.
• Processor: DSP, 400 million operations per second.
• Speed: up to 100 images in 2 seconds in Cornea Fine Scan mode.
• Evaluated elevation points: up to 138,000.
• Curvature range: 3–38 mm / 9–99 D.
• Precision: ±0.1 D.
• Reproducibility: ±0.1 D.
• Operating distance: 80 mm.
• Dimensions (W × D × H): 275 × 320–400 × 500–530 mm.
• Measuring head weight: 7.8 kg.
• Maximum power draw: 35 W.

Benefits

For the clinician and clinic

• measurement of both anterior and posterior corneal surfaces with elevation mapping;
• non-contact pachymetry and three-dimensional anterior segment analysis;
• measurements do not rely on tear-film reflections as Placido-based topography does;
• one platform supports refractive, cataract, anterior chamber and contact lens applications;
• Belin/Ambrósio Enhanced Ectasia Display for comprehensive corneal tomographic analysis;
• Holladay EKR and other software tools for previously treated and complex corneas;
• optional integration with DICOM and PACS.

For the patient

• non-contact examination;
• a standard scan takes approximately 2 seconds;
• a single examination provides information about both corneal surfaces, corneal thickness and the anterior chamber;
• tomographic analysis helps the clinician assess the cornea before laser vision correction;
• visual maps and images can be used to explain examination findings.

Oertli OS 4 Ophthalmic Surgical Platform

Overview

The Oertli OS 4 is a multifunctional ophthalmic surgical platform for cataract, vitreoretinal and glaucoma surgery.

The system combines three fluidics options, easyPhaco® and SPEEP® technologies, a pneumatic Continuous Flow Cutter with a permanently open port, high-frequency anterior segment functions, two independent LED endoillumination sources and a fully integrated 532 nm endolaser.

Its configuration allows a single platform to support different stages of anterior and posterior segment surgery.

Manufacturer

Oertli Instrumente AG, Berneck, Switzerland.

Oertli develops and manufactures ophthalmic surgical systems, instruments and consumables in Switzerland.

Please note: OS 4 belongs to the generation preceding the current OS 4 Up platform. Specifications of the two systems, particularly vitrectomy cut rate, display size and selected fluidics features, should therefore not be mixed.

Applications

Cataract surgery

OS 4 is used for ultrasonic cataract phacoemulsification with easyPhaco® technology.

The system supports:

• ultrasonic phacoemulsification;
• Linear, PULSE, BURST and CMP operating modes;
• Occlusion Mode in applicable software configurations;
• coaxial irrigation and aspiration;
• easyPhaco®, CO-MICS and MICS techniques;
• high-frequency capsulotomy.

easyPhaco® combines easyTip geometry, high infusion capacity and controlled aspiration to support lens-fragment holdability and removal.

High-frequency capsulotomy

HF Capsulotomy uses high-frequency energy to open the anterior lens capsule without conventional mechanical tearing with forceps or a needle.

According to Oertli, the method may be considered in selected challenging situations including:

• absent or poor red reflex;
• hypermature cataract;
• intumescent cataract;
• traumatic cataract;
• juvenile cataract;
• small pupil;
• uncontrolled capsulorhexis or capsular phimosis.

Selection of HF Capsulotomy instead of conventional capsulorhexis is determined by the surgeon according to the clinical situation.

Vitreoretinal surgery

OS 4 is used for vitrectomy and other posterior segment procedures.

The Continuous Flow Cutter can be used during surgery for conditions such as:

• vitreomacular interface disorders;
• macular holes;
• epiretinal membranes;
• vitreous opacities;
• retinal detachment;
• complications of diabetic retinopathy;
• other vitreoretinal disorders.

The disease itself is not a device-specific indication. Clinical indications for vitrectomy are determined by the vitreoretinal surgeon.

Endolaser therapy

In an applicable configuration, OS 4 incorporates a fully integrated 532 nm endolaser.

The laser is used for intraocular photocoagulation during vitreoretinal surgery.

The system includes an automatic laser protection filter that enters the optical path when the laser is activated.

Laser power can be controlled from the system and compatible multifunction foot pedal.

Glaucoma surgery

OS 4 supports High Frequency Deep Sclerotomy (HFDS®).

HFDS is an implant-free ab interno minimally invasive glaucoma surgery procedure. A dedicated tip is introduced through a paracentesis and uses high-frequency diathermy to create small sclerotomy pockets in the iridocorneal angle.

The procedure is intended to reduce resistance to aqueous outflow.

HFDS can be performed as a stand-alone procedure or in combination with cataract surgery in appropriately selected patients.

Technology and features

Three-pump fluidics system

OS 4 combines three aspiration-fluidics options:

• peristaltic;
• Venturi;
• SPEEP®.

All three pump systems use a standardized cassette type. The surgeon can select the fluidics principle according to the surgical step and required aspiration characteristics.

SPEEP®

SPEEP® is based on a peristaltic pump principle while allowing vacuum and maximum flow to be controlled independently.

Flow is limited to a preset maximum, while vacuum can be regulated through the foot pedal.

This approach enables:

• control of holdability at the instrument opening;
• direct vacuum control during tissue manipulation;
• limitation of aspiration flow;
• aspiration control during both free flow and occlusion.

SPEEP® can be used in both anterior and posterior segment surgery.

easyPhaco®

easyPhaco® is a phacoemulsification concept in which tip geometry, infusion and aspiration function as an integrated fluidics system.

The angled easyTip opening is designed to hold lens fragments at the tip. During occlusion, ultrasound energy acts directly on the retained fragment, which is subsequently aspirated.

According to the manufacturer, the system is designed to provide:

• fragment followability;
• controlled holdability;
• effective aspiration;
• anterior chamber stability with recommended settings.

The titanium easyPhaco handpiece incorporates six piezo crystals, has an external diameter of approximately 13 mm and weighs approximately 42 g. The easyTip family covers incision configurations from approximately 1.6 to 3.2 mm.

Occlusion Mode

Updated OS 4 configurations include Occlusion Mode for the peristaltic system.

In this mode, phaco energy is activated once a preset vacuum threshold has been reached. This links ultrasound delivery to tip occlusion.

The function is an additional phaco control mode and does not replace individual adjustment of ultrasound, vacuum and aspiration settings by the surgeon.

Continuous Flow Cutter

The Continuous Flow Cutter is a pneumatic push-pull vitrectomy probe.

Unlike a conventional guillotine cutter, its port remains permanently open. A double-edged blade approximately 0.1 mm wide cuts in both directions.

For the OS 4:

• maximum cut rate is 10,000 cpm;
• pneumatic push-pull drive;
• permanently open port;
• continuous aspiration;
• support for small-gauge instrumentation including 27G;
• minimum port-to-tip distance at 27G is approximately 0.17 mm.

Because the port remains permanently open, the conventional duty-cycle concept is essentially not applicable to this cutter. According to Oertli, the design produces less retinal traction than the previous SPS cutter generation.

The newer OS 4 Up should be distinguished from OS 4: its Continuous Flow Cutter operates at up to 15,000 cpm.

Power LED and Power LED Plus

OS 4 incorporates two independent LED endoillumination sources.

Power LED provides adjustable light intensity. Power LED Plus additionally allows the color spectrum to be modified by mixing yellow and blue components.

This enables adjustment of:

• illumination intensity;
• color spectrum;
• image contrast

according to the surgical situation and surgeon preference.

Oertli reports up to 45% higher maximum Power LED output compared with the previous generation under specified test conditions.

Infusion and fluid-air exchange

OS 4 supports:

• passive gravity infusion;
• active Gas-Forced Infusion;
• automatic three-way stopcock for BSS-to-air exchange.

In updated OS 4 configurations, infusion settings can be changed from the foot pedal in five-unit increments.

During vitreoretinal surgery, Irrigation Off can temporarily suspend irrigation for a defined period, for example when the surgeon intentionally lowers IOP to inspect the peripheral retina.

These functions depend on the software version and configuration of the individual system.

532 nm endolaser

The integrated endolaser operates at 532 nm.

The system provides:

• laser power control;
• control through the multifunction foot pedal;
• automatic laser protection filter insertion;
• acoustic safety signals;
• compatibility with a range of endolaser probes.

The laser protection filter automatically enters the optical pathway during laser use and is removed after laser delivery.

Multifunction foot pedal

OS 4 uses a wireless dual-linear foot pedal.

Depending on configuration it supports:

• linear control;
• dual-linear control;
• function switching;
• aspiration control;
• vacuum control in SPEEP®;
• Cut/Aspiration and Aspiration/Cut switching;
• endolaser control;
• individualized programming.

The system supports more than 100 foot-control assignments and individual settings for multiple surgeons.

Touchscreen interface

OS 4 incorporates a 15-inch glass touchscreen.

The system supports:

• surgical parameter control;
• user-specific settings;
• audio feedback;
• voice confirmation in multiple languages.

According to Oertli, the platform can be ready for surgery in under 30 seconds following the appropriate setup.

Technical specifications

• Type: ophthalmic surgical platform for cataract, vitreoretinal and glaucoma surgery.
• Manufacturer: Oertli Instrumente AG, Switzerland.
• Fluidics: Peristaltic, Venturi and SPEEP®.
• Cassette: one standardized cassette type for all three pump systems.
• Infusion: passive gravity and active GFI.
• BSS / air exchange: automatic three-way stopcock.
• Phacoemulsification: easyPhaco®.
• Phaco modes: Linear, PULSE, BURST, CMP.
• Additional mode: Occlusion Mode.
• Phaco handpiece: easyPhaco with six piezo crystals.
• Capsulotomy: High Frequency Capsulotomy.
• Glaucoma: HFDS® ab interno MIGS.
• Diathermy: bipolar high-frequency.
• Vitrectomy: pneumatic Continuous Flow Cutter.
• Cutter drive: push-pull.
• Maximum Continuous Flow Cutter rate on OS 4: 10,000 cpm.
• Gauges: including 23G, 25G and 27G depending on instrument.
• Port-to-tip distance at 27G: approximately 0.17 mm.
• Illumination: two independent Power LED sources.
• Power LED Plus: adjustable color spectrum.
• Endolaser: integrated, 532 nm.
• Laser safety: automatic protection filter and acoustic signals.
• Display: 15-inch touchscreen.
• Foot pedal: wireless dual-linear multifunction control.
• User settings: programmable for multiple surgeons.
• System readiness: under 30 seconds according to the manufacturer.
• OS 4 Up: separate newer generation with Continuous Flow Cutter up to 15,000 cpm and 17-inch user interface.

Benefits

For the surgeon and surgical team

• cataract, vitreoretinal and glaucoma surgery on one platform;
• choice of Peristaltic, Venturi and SPEEP® fluidics;
• independent vacuum and maximum-flow control with SPEEP®;
• one standardized cassette across different pump systems;
• easyPhaco® for controlled phacoemulsification;
• HF Capsulotomy for selected challenging cases;
• Continuous Flow Cutter with permanently open port and up to 10,000 cpm;
• instrumentation down to 27G;
• dual independent LED illumination sources;
• Power LED Plus color-spectrum adjustment;
• integrated 532 nm endolaser;
• automatic laser protection filter;
• HFDS® for implant-free ab interno MIGS;
• wireless programmable dual-linear foot pedal;
• 15-inch touchscreen interface.

For the patient

• a single platform supports multiple types of ophthalmic surgery;
• microincisional vitrectomy can be performed with instrumentation down to 27G;
• the Continuous Flow Cutter is designed to reduce traction during vitreous removal;
• endoillumination intensity and spectrum can be adapted to the surgical situation;
• HF Capsulotomy provides an additional method for opening the anterior capsule in selected difficult cases;
• HFDS is performed ab interno without implantation of a drainage implant.

Optos Daytona (P200T) Ultra-Widefield Scanning Laser Ophthalmoscope

Overview

The Optos Daytona is a digital scanning laser ophthalmoscope designed for ultra-widefield retinal imaging.

A single non-contact optomap® image captures up to 200°, representing approximately 82% of the retinal surface. Standard image acquisition takes less than 0.4 seconds.

Daytona uses 532 nm and 635 nm scanning lasers to provide composite color imaging, separate sensory retinal and choroidal views, and green autofluorescence.

The system is designed for non-mydriatic imaging and can acquire useful retinal images without pharmacologic pupil dilation in many patients.

Manufacturer

Optos plc, Dunfermline, Scotland, United Kingdom.
Optos plc has been a wholly owned subsidiary of Nikon Corporation since May 2015.

The P200T has U.S. FDA 510(k) clearance K111628.

Daytona Plus was introduced in 2016 as an updated Daytona generation associated with the OptosAdvance™ software platform.

Applications

Retinal and peripheral fundus imaging

The up-to-200° optomap® field provides simultaneous documentation of central and peripheral retinal structures.

The system can contribute to imaging in patients with:

• peripheral retinal degeneration;
• retinal tears;
• retinal detachment;
• diabetic retinopathy;
• age-related macular degeneration;
• retinal vascular disorders;
• posterior segment inflammatory disease;
• choroidal lesions;
• high myopia;
• other retinal and choroidal disorders.

The large field is particularly useful for documenting abnormalities outside the area normally covered by conventional fundus photography.

optomap® is an imaging modality and does not replace a clinically indicated dilated peripheral retinal examination.

Diabetic retinopathy

Ultra-widefield imaging can document abnormalities in both central and peripheral retinal areas.

Images can be used for:

• initial assessment;
• lesion documentation;
• longitudinal follow-up;
• visit-to-visit comparison;
• compatible telehealth workflows.

Age-related macular degeneration and RPE disorders

Color imaging and green autofluorescence provide information about central and peripheral retinal and retinal pigment epithelium abnormalities.

Peripheral retinal tears and detachment

The up-to-200° field facilitates documentation of peripheral retinal abnormalities including breaks, degenerative lesions and areas of retinal detachment.

Eye Steering enables additional imaging while the patient directs gaze nasally, temporally, superiorly or inferiorly.

Glaucoma

Daytona can acquire color and stereo images of the optic nerve head for documentation and longitudinal comparison.

Fundus photography remains an adjunct and does not replace other required glaucoma investigations.

Choroidal and retinal lesions

Ultra-widefield color imaging and the separate Choroidal View can document the location and appearance of central and peripheral lesions.

Screening and routine examinations

Daytona is designed for rapid non-mydriatic retinal imaging and can be used when broad retinal documentation is required.

Technology and features

optomap®: up to 200° in a single capture

A standard optomap® image captures up to 200° or approximately 82% of the retinal surface. Acquisition takes less than 0.4 seconds and is non-contact.

Ultra-Widefield Imaging

Daytona acquires a large retinal field in a single capture rather than constructing the overview from a series of conventional fundus photographs.

Dual scanning lasers

Daytona uses a 532 nm green laser and a 635 nm red laser. The green channel predominantly represents sensory retinal structures, while the red wavelength penetrates more deeply and is used for Choroidal View.

3-in-1 Color Depth Imaging™

3-in-1 Color Depth Imaging™ provides optomap color RG, Sensory Retina View, and Choroidal View. Green autofluorescence is a separate imaging modality.

Green autofluorescence

Daytona provides widefield green autofluorescence with 532 nm excitation without intravenous contrast.

Non-mydriatic imaging

According to Optos, Daytona can image through pupils as small as approximately 2 mm and through many cataracts.

Eye Steering

Eye Steering supports additional peripheral imaging beyond the standard central optomap field.

Auto-montage

Compatible software can combine multiple images into a field of up to 220°.

Stereo imaging

Daytona supports acquisition of stereoscopic image pairs.

ProView™

ProView™ corrects projection distortion when the curved retinal surface is displayed on a flat screen.

3D Wrap®

3D Wrap® displays the optomap image on a three-dimensional model of the eye for patient communication and teaching.

OptosAdvance™

Current Daytona configurations use OptosAdvance™ for image viewing, comparison, archiving, sharing and DICOM-integrated workflows.

Technical specifications

• Type: ultra-widefield scanning laser ophthalmoscope
• Manufacturer: Optos plc, United Kingdom (Parent company: Nikon Corporation)
• Model: P200T / A10600
• Standard field: up to 200°
• Retinal coverage: approximately 82%
• Auto-montage: up to 220°
• Lasers: Red laser (635 nm), Green laser (532 nm)
• Imaging modalities: optomap color RG, Sensory Retina, Choroidal, green autofluorescence
• optomap / optomap plus resolution: 20 µm / 14 µm
• Acquisition time: less than 0.4 seconds
• Operation: Non-contact, Non-mydriatic (Minimum pupil size ~2 mm)
• Features: Eye Steering, Stereo imaging, ProView™, OptosAdvance™
• Compatibility: DICOM compatible
• Laser safety: Class 1
• Weight: up to 28 kg
• Dimensions: approximately 425 × 475 × 800 mm
• Maximum power consumption: 300 VA
• FDA 510(k): K111628

Benefits

For the clinician and clinic

• up to 200° or approximately 82% of the retina in one capture;
• standard image acquisition in less than 0.4 seconds;
• simultaneous central and peripheral retinal documentation;
• non-mydriatic imaging;
• dual-wavelength retinal visualization;
• green autofluorescence without intravenous contrast;
• Eye Steering for additional peripheral imaging;
• auto-montage up to 220°;
• stereo imaging;
• ProView™ projection correction;
• DICOM integration.

For the patient

• non-contact examination;
• pupil dilation is not required in many examinations;
• image capture takes less than 0.4 seconds;
• green autofluorescence requires no intravenous contrast;
• Class 1 laser safety when operated according to instructions;
• retinal images can be shown during consultation.

Optovue SOLIX Optical Coherence Tomographer

Overview

The Optovue SOLIX is a spectral-domain optical coherence tomography (SD-OCT) system with OCT angiography and an integrated color fundus camera. Its FullRange® platform is designed for anterior and posterior segment imaging and operates at a scan speed of 120,000 A-scans per second.

The system combines structural OCT imaging, OCT angiography, fundus photography and anterior segment assessment within a single diagnostic platform.

Manufacturer

Optovue, a Visionix brand.

Regulatory status:

• SOLIX has FDA 510(k) clearance K222166;
• AngioVue® is indicated as an aid in visualization of retinal and choroidal vascular structures;
• AngioAnalytics™ provides quantitative measurement of vessel density, foveal avascular zone, retinal and nerve fiber layer thickness and optic disc parameters;
• the integrated reference database is used to compare selected structural OCT measurements of the retina, RNFL and optic disc against a database of known normal subjects;
• the FDA-cleared configuration does not include a separate OCT-A normative database.

Applications

Retina and macula

SOLIX provides imaging of the retina, vitreous and choroid. FullRange imaging increases scan width and depth and can be useful when examining highly myopic eyes.

Available retinal tools include:

• structural retinal OCT;
• retinal thickness mapping;
• En Face OCT;
• FullRange Retina;
• iWellness;
• AngioWellness;
• AngioVue® OCT-A;
• 3D vascular rendering.

AngioWellness combines structural retinal and ganglion cell information with vascular metrics and can support comprehensive assessment of patients with retinal vascular abnormalities or suspected glaucoma.

Glaucoma

The SOLIX glaucoma package combines structural assessment of the optic nerve head, retinal nerve fiber layer and ganglion cell complex with vascular analysis.

The system provides:

• RNFL thickness measurements;
• GCC analysis;
• optic nerve head parameters;
• radial peripapillary capillary density maps;
• comparison of structural measurements against a reference database;
• longitudinal RNFL and GCC trend analysis.

Scanning with SSADA and Motion Correction Technology can generate structural OCT and OCT-A information with AngioAnalytics™ metrics.

DualTrac™, Motion Correction Technology, SSADA, projection artifact reduction and automated segmentation are used to improve measurement stability and subsequent analysis.

Anterior segment

FullRange® imaging allows examination of the anterior chamber from the anterior corneal surface to the anterior surface of the crystalline lens. Selected scan modes can also image the entire crystalline lens.

Angle Scan with a four-up display enables visualization and quantitative assessment of anterior chamber angle structures.

The 10 mm Corneal Layer Map provides:

• epithelial thickness;
• stromal thickness;
• total corneal thickness;
• change analysis between examinations.

These measurements can support corneal assessment before refractive procedures and follow-up of patients with keratoconus and ocular surface disorders.

Topography and aberrometry

An optional OCT topography module is available for SOLIX.

Depending on configuration, it provides:

• axial maps;
• tangential maps;
• elevation maps;
• anterior and posterior corneal surface data;
• pachymetry;
• epithelial thickness mapping;
• Zernike coefficients;
• lower-order and higher-order aberration data;
• visual acuity simulation.

Up to six selected maps can be displayed simultaneously.

These measurements can support assessment before refractive and cataract surgery, phakic IOL planning and specialty contact lens fitting.

Fundus camera

SOLIX incorporates a non-contact color fundus camera.

Features include:

• color fundus photography;
• 5 MP resolution;
• 45° field of view;
• 35° small-pupil mode;
• pseudo red-free display;
• external color photography;
• external infrared imaging.

Infrared imaging can be used to visualize external ocular structures including the upper and lower eyelids.

Technology and features

120,000 A-scans per second

SOLIX operates at up to 120,000 A-scans per second.

The high acquisition rate supports dense volumetric data sets for anterior and posterior segment imaging while reducing acquisition time.

Combined with motion correction and multi-volume averaging, the higher scan rate supports stable, detailed diagnostic imaging.

FullRange®

FullRange® extends OCT scan width and depth.

Key parameters include:

• posterior segment: scan width up to 16 mm and depth up to 6.25 mm;
• anterior segment: scan length up to 18 mm and depth up to 6.25 mm.

FullRange Retina provides extended visualization of posterior structures including the vitreous, retina and choroid.

FullRange Anterior provides a wide view of the anterior chamber in a single scan.

AngioVue® OCT-A and AngioAnalytics™

AngioVue® provides non-contact OCT angiography without intravenous contrast injection.

The system visualizes retinal and choroidal microvasculature and provides quantitative AngioAnalytics™ measurements.

Depending on the protocol, measurements include:

• vessel density;
• foveal avascular zone;
• retinal layer thickness;
• retinal nerve fiber layer thickness;
• optic disc parameters.

Available single OCT-A retinal scan sizes include:

• 3 × 3 mm;
• 6.4 × 6.4 mm;
• 9 × 9 mm;
• 12 × 12 mm.

AngioVue QuadMontage combines four 9 × 9 mm scans to generate a widefield montage of approximately 16 × 16 mm.

DualTrac™ Motion Correction Technology

DualTrac™ combines eye tracking during image acquisition with software-based post-processing.

Motion Correction Technology registers volumes acquired in different directions to reduce motion-related artifacts.

This is particularly relevant to volumetric OCT and OCT-A imaging, where motion can affect vascular geometry and quantitative measurements.

Data processing

SOLIX incorporates several OCT and OCT-A processing technologies.

Depending on the protocol, these include:

• SSADA;
• Motion Correction Technology;
• DualTrac™;
• 3D PAR 2.0 projection artifact reduction;
• multi-volume averaging;
• automated segmentation;
• pixel-by-pixel deviation mapping;
• 3D vascular rendering.

These tools support structured analysis of the retina, optic nerve head and retinal vasculature.

Technical specifications

• Type: spectral-domain optical coherence tomography system with OCT angiography.
• Scan speed: 120,000 A-scans per second, 120 kHz.
• Axial resolution: 5 µm in tissue.
• Transverse resolution: 15 µm in tissue.
• OCT light source: superluminescent diode, approximately 840 nm.
• Posterior FullRange: scan width up to 16 mm and depth up to 6.25 mm.
• Anterior FullRange: scan length up to 18 mm and depth up to 6.25 mm.
• OCT-A: single scans up to 12 × 12 mm.
• AngioVue QuadMontage: four 9 × 9 mm scans producing a widefield montage of approximately 16 × 16 mm.
• Corneal map: 10 mm, 16 meridians.
• Fundus camera: integrated, non-contact color camera.
• Fundus camera resolution: 5 MP.
• Fundus camera field of view: 45°, 35° in small-pupil mode.
• External imaging: color and infrared, 940 nm.
• Instrument dimensions (W × D × H): 1072 × 600 × 610 mm.
• Table dimensions (W × D × H): 952 × 600 × 913 mm.
• System weight: 95 kg.
• DICOM: Modality Worklist and Storage.

Benefits

For the clinician and clinic

• structural OCT, OCT angiography, anterior segment imaging and fundus photography within one system;
• 120 kHz scan speed;
• FullRange anterior and posterior segment imaging;
• a single protocol can combine structural and vascular data;
• AngioAnalytics™ provides quantitative vascular metrics;
• structural RNFL, retinal and optic disc measurements can be compared with a reference database and monitored over time;
• 10 mm epithelial, stromal and total corneal thickness mapping;
• optional OCT topography and corneal aberrometry;
• integrated color fundus photography and external infrared imaging.

For the patient

• OCT and OCT-A examinations are non-contact;
• OCT angiography does not require intravenous dye injection;
• high scan speed reduces image acquisition time;
• multiple structural and vascular diagnostic data sets can be obtained during the same visit;
• color photographs, maps and 3D images can help the clinician explain examination findings.

SCHWIND AMARIS® 500E Excimer Laser

Overview

The SCHWIND AMARIS® 500E is a compact excimer laser for refractive and therapeutic corneal surgery. The system operates at a repetition rate of 500 Hz, incorporates active 5D eye tracking and uses a 0.54 mm laser spot with a Super-Gaussian profile.

The AMARIS® 500E supports conventional and customized ablation profiles, touch-free SmartSurfACE treatment and treatment planning with the SCHWIND CAM software suite.

Manufacturer

SCHWIND eye-tech-solutions GmbH, Germany.

The company specializes in laser and diagnostic systems for refractive and therapeutic corneal surgery.

Applications

SmartSurfACE (TransPRK)

SmartSurfACE combines transepithelial photorefractive keratectomy, or TransPRK, with SmartPulse Technology.

The procedure is performed without mechanical contact with the cornea, suction or creation of a corneal flap. The laser sequentially removes the epithelium and performs refractive stromal ablation within a single laser treatment step.

SmartPulse is used to optimize the geometry of the resulting corneal surface and is particularly relevant to surface procedures, where no corneal flap covers the treated stromal surface.

Conventional refractive surgery

The SCHWIND AMARIS® 500E can be used for the excimer laser stage of several laser vision correction procedures:

• LASIK;
• Femto-LASIK;
• PRK;
• LASEK;
• TransPRK.

The system is used to correct myopia, hyperopia and astigmatism. The appropriate treatment method and correction range are determined after diagnostic evaluation, taking into account corneal parameters and the approved indications applicable to the specific system configuration.

Customized ablation

SCHWIND CAM enables planning of conventional and customized ablation profiles.

Depending on the diagnostic data and software modules used, treatment planning can incorporate:

• refraction;
• corneal topography;
• corneal wavefront data;
• ocular wavefront data;
• pachymetry;
• epithelial mapping data.

The ORK-CAM module is among the tools used for refractive treatment planning.

Therapeutic corneal surgery

The system supports phototherapeutic keratectomy (PTK).

The PTK-CAM module enables planning of superficial or deeper therapeutic ablation for selected corneal abnormalities. Ablation areas can be circular, elliptical or individually shaped depending on the clinical requirement.

Technology and features

500 Hz repetition rate and 0.54 mm spot

The laser operates at a repetition rate of 500 Hz.

During LASIK treatment for myopia without astigmatism, one diopter can be ablated in approximately 2.0 seconds under the following conditions:

• vertex distance: 12.5 mm;
• optical zone: 6 mm.

Actual laser treatment time depends on the amount of refractive correction, the selected ablation profile and optical zone parameters.

The laser spot diameter is 0.54 mm FWHM. A Super-Gaussian profile and flying-spot delivery are used. The small spot size supports detailed modelling of the ablation profile and smooth transition zones across the treated corneal surface.

Automatic Fluence Level Adjustment (AFLA)

Automatic Fluence Level Adjustment manages the relationship between the total number of laser pulses and the energy density delivered.

Approximately:

• 80% of the ablation is performed at high fluence;
• around 20% is performed at lower fluence for finer surface modelling.

This combination allows the main ablation stage to be performed rapidly while providing finer surface treatment during the final portion of the ablation.

Active 5D eye tracker

The eye tracking system operates at a sampling rate of 1050 Hz and compensates for eye movements during laser treatment.

The 5D tracking system accounts for:

• X-axis displacement;
• Y-axis displacement;
• horizontal rolling movement;
• vertical rolling movement;
• rotation around the visual axis using static and dynamic cyclotorsion control.

The system also monitors changes in pupil size and compensates for pupil centroid shift.

Tracking is based on both pupil and limbus information.

Overall system reaction time for the AMARIS® 500E is 3 ms.

SmartPulse Technology

SmartPulse optimizes the geometric model of the corneal surface and the spatial distribution of laser pulses.

The technology is designed to produce a smoother surface geometry following ablation. This is particularly relevant to surface treatments such as SmartSurfACE, where epithelial healing takes place directly over the treated stromal surface.

Manufacturer information and published clinical studies associate SmartPulse with earlier functional visual recovery following surface laser treatment.

Intelligent Thermal Effect Control (ITEC)

ITEC manages laser pulse sequencing and spatial distribution with consideration of thermal load.

The system calculates where subsequent pulses should be placed so that individual corneal locations have time to cool. This helps limit localized heat accumulation during high-frequency ablation.

Online pachymetry

Optional non-contact online pachymetry is available for the AMARIS® 500E.

The optical system measures corneal thickness and displays changes on the treatment screen during the procedure. Measurements can be obtained at different treatment stages, including before, during and after laser ablation.

The measurement data can be documented in the treatment log.

SCHWIND CAM

SCHWIND CAM is a modular treatment planning software suite for refractive and therapeutic procedures on the AMARIS platform.

Depending on the configuration, available modules include:

• ORK-CAM for refractive treatment;
• PresbyMAX for presbyopia treatment;
• PTK-CAM for therapeutic ablation.

The system allows patient-specific diagnostic information to be incorporated into individualized laser treatment planning.

Technical specifications

• Laser type: ArF excimer laser.
• Wavelength: 193 nm.
• Application: refractive and therapeutic corneal surgery.
• Repetition rate: 500 Hz.
• Ablation time: approximately 2.0 s per diopter for LASIK treatment of myopia without astigmatism at a 12.5 mm vertex distance and 6 mm optical zone.
• Laser spot diameter: 0.54 mm FWHM.
• Spot profile: Super-Gaussian.
• Beam delivery: flying spot with Automatic Fluence Level Adjustment.
• Eye tracking: active 5D.
• Eye tracker sampling rate: 1050 Hz.
• Tracking references: pupil and limbus.
• Pupil centroid shift compensation: supported.
• Cyclotorsion control: static and dynamic Advanced Cyclotorsion Control.
• Overall system reaction time: 3 ms.
• Thermal effect control: Intelligent Thermal Effect Control.
• Pachymetry: optional non-contact online pachymetry.
• Treatment planning: SCHWIND CAM.
• Configuration: compact and ergonomic with a small footprint.

Benefits

For the clinician and clinic

• 500 Hz repetition rate with approximately 2.0 s per diopter under standard myopic LASIK conditions;
• compact footprint;
• support for LASIK, Femto-LASIK, PRK, LASEK and TransPRK workflows;
• touch-free SmartSurfACE treatment;
• customized treatment planning with SCHWIND CAM;
• active 5D tracking with cyclotorsion and pupil position monitoring;
• AFLA for automatic management of fluence levels;
• ITEC for management of thermal load during ablation;
• optional non-contact corneal thickness monitoring during treatment.

For the patient

• SmartSurfACE is performed without suction or creation of a corneal flap;
• short laser treatment time supported by the 500 Hz repetition rate;
• active eye tracking monitors eye position throughout ablation;
• SmartPulse optimizes corneal surface geometry following laser treatment;
• ITEC limits localized heat accumulation during ablation;
• the treatment method and ablation profile can be selected according to the results of a comprehensive diagnostic examination.

Anterior Segment Analyzer SCHWIND SIRIUS

Overview

SCHWIND SIRIUS is a non-contact "2 in 1" diagnostic system combining a rotating Scheimpflug camera with Placido-disc corneal topography. A single acquisition provides a three-dimensional assessment of the cornea and anterior segment, including pachymetry, topography, and analysis of both anterior and posterior corneal surfaces.

Combining the two imaging technologies provides data for both corneal diagnostics and the planning of refractive and therapeutic procedures.

Manufacturer

Manufacturer: CSO SRL, Italy.

SCHWIND eye-tech-solutions supplies the system as part of its diagnostic and surgical ecosystem.

SIRIUS diagnostic data can be transferred to SCHWIND CAM treatment planning software and used for planning procedures on SCHWIND AMARIS laser systems. Integration with later platforms, including SCHWIND ATOS, depends on the device generation and installed software configuration.

Applications

Refractive and Therapeutic Corneal Surgery

SCHWIND SIRIUS is used for comprehensive corneal assessment before laser procedures.

The system provides data for planning procedures including:

• FemtoLASIK;
• SmartSurfACE / TransPRK;
• PRK;
• PTK;
• customized corneal ablation.

The corneal wavefront is calculated from measured corneal geometry and can be imported into SCHWIND CAM for individualized ablation planning.

Compatible SIRIUS configurations can provide static cyclotorsion information for treatment planning and transfer to SCHWIND AMARIS.

Pachymetry maps can also be used when planning pachymetry-assisted laser keratoplasty (PALK).

Keratoconus Screening and Follow-Up

Combining information from the anterior and posterior corneal surfaces with pachymetry, curvature, and elevation data enables the assessment of tomographic and topographic signs associated with keratoconus and other ectatic disorders.

SIRIUS can be used:

• when evaluating candidates for laser vision correction;
• to assess corneal shape and thickness;
• for longitudinal comparison of corneal changes;
• when planning intracorneal ring segment implantation.

The measurements form part of a comprehensive diagnostic assessment and should not be used in isolation to diagnose or predict postoperative ectasia.

Anterior Segment and Glaucoma Screening

Scheimpflug imaging enables assessment of anterior segment geometry.

The system can calculate parameters including:

• anterior chamber depth;
• anterior chamber volume;
• iridocorneal angle;
• corneal measurements.

These parameters can contribute to the comprehensive assessment of patients at risk of anterior chamber angle closure. SIRIUS does not replace tonometry, perimetry, optic nerve assessment, or other components of a complete glaucoma evaluation.

Pupillometry

Integrated pupillometry measures pupil diameter and pupil-center position under different illumination conditions.

Standardized lighting levels include:

• photopic: 40 lux;
• mesopic: 4 lux;
• scotopic: 0.04 lux.

Pupil size and center displacement can be taken into account when selecting the optical zone and centration strategy for refractive procedures.

Technology and Features

Hybrid System: Scheimpflug Camera and Placido Disc

SCHWIND SIRIUS combines two corneal imaging technologies.

The 22-ring Placido-disc topographer provides detailed curvature information from the anterior corneal surface.

The 360° rotating Scheimpflug camera acquires a series of 25 radial optical sections and provides information about:

• the anterior corneal surface;
• the posterior corneal surface;
• corneal thickness;
• the anterior chamber;
• the iris;
• the anterior crystalline lens surface.

Data from both imaging systems are combined by the software into a unified model of the cornea and anterior segment.

Light Source and Data Density

Scheimpflug imaging uses a 475 nm blue LED light source without ultraviolet radiation.

SIRIUS acquires a high density of information from both corneal surfaces for curvature, elevation, and pachymetry mapping.

The precise number of measurement points depends on the device version and acquisition mode. Different generations of SIRIUS and published clinical studies report different values, so specifications for an installed system should be confirmed against its technical documentation.

Acquisition Speed

During a standard acquisition with 25 Scheimpflug sections, anterior segment imaging takes approximately one second.

The examination is non-contact. The patient fixates on an internal target while the system acquires the required images.

Corneal Wavefront

SIRIUS calculates corneal aberrations from the measured geometry of the cornea.

The analysis includes:

• lower-order aberrations;
• higher-order aberrations;
• Zernike coefficients;
• assessment of corneal optical quality.

Corneal wavefront data can be incorporated into customized refractive treatment planning with SCHWIND CAM.

Measured Parameters

Depending on the installed software, the system can assess:

• anterior and posterior corneal curvature;
• anterior and posterior corneal elevation;
• pachymetry;
• corneal refractive power;
• corneal wavefront;
• anterior chamber depth;
• anterior chamber volume;
• iridocorneal angle;
• pupil diameter and position;
• keratometric parameters.

Technical Specifications

• Type: non-contact corneal and anterior segment analyzer.
• Technologies: rotating Scheimpflug camera and Placido-disc topography.
• Topographer: 22-ring Placido disc.
• Scheimpflug camera: 360° rotation.
• Standard acquisition: 25 radial sections.
• Light source: 475 nm blue LED, UV-free.
• Standard scan acquisition time: approximately 1 second.
• Measurement method: non-contact.
• Pupillometry: static and dynamic under defined illumination conditions.
• Corneal aberrometry: ray-tracing analysis.
• Integration: diagnostic data export to SCHWIND CAM.
• Static cyclotorsion: data transfer for compatible SCHWIND AMARIS configurations.
• SCHWIND ATOS integration: dependent on SIRIUS generation and installed software.

Benefits

For the Clinician and Clinic

• Scheimpflug tomography and Placido topography combined in one device;
• analysis of both anterior and posterior corneal surfaces;
• pachymetry, topography, corneal aberrometry, and anterior chamber parameters;
• integrated pupillometry;
• assessment of tomographic and topographic signs associated with keratoconus;
• data for intracorneal ring segment planning;
• pachymetric data that can support PALK planning;
• diagnostic data transfer to SCHWIND CAM and compatible laser systems.

For the Patient

• non-contact examination;
• no topical anesthesia is required for measurement;
• standard acquisition of 25 sections takes approximately one second;
• a single examination provides information about corneal shape, thickness, and optical properties;
• comprehensive analysis supports corneal assessment before laser vision correction.

WaveLight® Oculyzer™ II Diagnostic System

Overview

The WaveLight® Oculyzer™ II is a non-contact diagnostic system for corneal and anterior segment tomography based on rotating Scheimpflug imaging technology. The system is based on OCULUS Pentacam® HR technology and is designed to operate within the diagnostic infrastructure of the WaveLight refractive suite.

During a single examination, the device acquires a series of optical cross-sectional images and generates a three-dimensional model of the anterior eye segment. Measurements extend from the anterior corneal surface to the posterior surface of the crystalline lens.

Manufacturer

WaveLight GmbH, Erlangen, Germany, an Alcon company.

The WaveLight® Oculyzer™ II is based on Pentacam® HR technology developed by OCULUS Optikgeräte GmbH, Wetzlar, Germany.

Availability of individual software modules and integration options depends on the system configuration and market.

Applications

Refractive surgery

The WaveLight® Oculyzer™ II is used for comprehensive corneal assessment before laser vision correction.

The system provides:

• analysis of the anterior and posterior corneal surfaces;
• elevation and curvature maps;
• pachymetry;
• assessment of corneal thickness distribution;
• anterior chamber analysis;
• evaluation of tomographic signs associated with keratoconus and other ectatic disorders.

The Belin/Ambrósio Enhanced Ectasia Display combines anterior and posterior corneal elevation data with analysis of corneal thickness distribution. The module can be used as part of the preoperative assessment before LASIK, Femto-LASIK, PRK and other refractive procedures.

The Oculyzer™ II can also support planning for phakic intraocular lens implantation by providing measurements of anterior chamber depth, corneal parameters and other anterior segment data.

Within the WaveLight system, the primary diagnostic device supplying topographic data for Contoura® Vision is the Topolyzer™ VARIO. In clinical practice, Oculyzer™ II measurements may additionally be used when assessing corneal vertex position and treatment centration.

Cataract surgery

The WaveLight® Oculyzer™ II provides keratometric, pachymetric and tomographic information that can contribute to cataract surgery planning.

The Holladay Report and Holladay EKR Detail Report support assessment of corneal refractive power, including in eyes that have previously undergone LASIK, PRK or other corneal refractive procedures.

The device does not measure axial length. Complete IOL power calculation therefore requires axial length data obtained by optical biometry or another appropriate biometric method.

Scheimpflug imaging can also be used to assess optical density within anterior segment structures and to visualize changes within the crystalline lens.

Anterior chamber assessment and pachymetry

The WaveLight® Oculyzer™ II measures anterior segment parameters that can be incorporated into a comprehensive ophthalmic examination.

The system determines:

• anterior chamber depth;
• anterior chamber volume;
• anterior chamber angle;
• corneal thickness.

Pachymetric information can help the clinician take corneal thickness into account when interpreting intraocular pressure measurements.

The Oculyzer™ II does not replace tonometry, perimetry, optic nerve assessment or the other examinations required for a complete glaucoma evaluation.

Technology and features

Rotating Scheimpflug camera

The integrated Scheimpflug camera rotates around the optical axis of the eye and acquires sequential images of the anterior segment from different angles.

The software uses these optical cross-sections to generate a three-dimensional model of the cornea and anterior segment.

The system acquires:

• up to 50 images during real-time measurement;
• up to 25,000 measurement points.

Rotational imaging provides information from both the anterior and posterior corneal surfaces and enables corneal thickness mapping across the measured area.

Anterior segment measurement

Measurements extend from the anterior corneal surface to the posterior surface of the crystalline lens.

A single examination can provide:

• anterior corneal topography;
• posterior corneal surface data;
• elevation maps;
• pachymetry maps;
• anterior chamber parameters;
• images of the cornea, iris and crystalline lens.

This combination of data supports comprehensive assessment of anterior segment geometry before refractive and other ophthalmic procedures.

Integration into the WaveLight suite

The WaveLight® Oculyzer™ II can operate within the digital infrastructure of the WaveLight refractive suite.

In applicable configurations, diagnostic data can be transferred through WaveLight software and networking solutions for subsequent treatment planning.

Different diagnostic devices within the ecosystem serve different purposes. The Oculyzer™ II provides Scheimpflug tomography of the anterior segment, while the Topolyzer™ VARIO uses Placido-disc technology and is used, among other applications, to provide topographic data for Contoura® Vision planning.

Non-contact scanning

During the examination, the patient positions the chin and forehead on the supports and fixates on a light target.

The measurement system does not touch the ocular surface. Acquisition takes only a few seconds and does not require a contact probe or topical anesthesia.

Technical specifications

• Type: diagnostic system with a rotating Scheimpflug camera, non-contact measurement.
• Technology base: Pentacam® HR, OCULUS.
• Image acquisition: up to 50 images during real-time measurement.
• Measurement points: up to 25,000.
• Measurement range: anterior corneal surface to posterior crystalline lens surface.
• Network integration: WaveLight solutions, including WaveNet™ in applicable configurations.

Benefits

For the clinician and clinic

• analysis of the anterior and posterior corneal surfaces in a single examination;
• elevation and pachymetry mapping;
• three-dimensional anterior segment analysis;
• Belin/Ambrósio Enhanced Ectasia Display for assessment of tomographic signs associated with ectasia;
• Holladay Report and Holladay EKR for assessment of corneal refractive power after previous refractive surgery;
• ability to use diagnostic data within the WaveLight diagnostic and surgical environment;
• non-contact acquisition of a large amount of anterior segment data in a single examination.

For the patient

• examination without contact with the ocular surface;
• scanning completed within a few seconds;
• a single examination provides information on both corneal surfaces, corneal thickness and the anterior chamber;
• tomographic parameters help the clinician assess corneal condition before laser vision correction;
• color maps and three-dimensional images can be used to explain examination findings clearly.

ZEISS IOLMaster® 700 оптикалық биометрі

Аннотация

ZEISS IOLMaster® 700 – Swept Source OCT технологиясына негізделген жанаспайтын оптикалық биометр. Жүйе көздің негізгі анатомиялық параметрлерін өлшейді, қасаң қабықтан торлы қабыққа дейінгі бойлық OCT-қималарын қалыптастырады және интраокулярлық линзалардың оптикалық күшін есептейді.

Бұл технология дәрігерге тек сандық биометриялық көрсеткіштерді алып қана қоймай, өлшеу жүргізілген анатомиялық құрылымдарды визуалды түрде бақылауға мүмкіндік береді.

Өндіруші

Carl Zeiss Meditec AG, Йена, Германия.

Регуляторлық мәртебесі:

• қолданыстағы еуропалық талаптарға сәйкес CE маркасы;
• АКШ-та FDA 510(k) рұқсаты;
• жекелеген функциялардың, формулалардың және бағдарламалық модульдердің қолжетімділігі елге және жабдықтың конфигурациясына байланысты.

Қолданылу салалары

Катаракта хирургиясы және ИОЛ есептеу

ZEISS IOLMaster® 700 катаракта операциясы алдында биометрия жүргізу және ИОЛ оптикалық күшін есептеу үшін қолданылады.

Жүйе линзаны есептеуге қажетті көз параметрлерін өлшейді және кең ауқымды формулаларды қолдайды, соның ішінде:

• Barrett Universal II;
• Total Keratometry болған кезде Barrett TK Universal II;
• Barrett Toric;
• Total Keratometry болған кезде Barrett TK Toric;
• Haigis;
• Haigis-T;
• Hoffer Q;
• Holladay 1;
• Holladay 2;
• SRK/T.

Сонымен қатар, қасаң қабықтың рефракциялық хирургиясының белгілі бір түрлерін бастан өткерген көздерге арналған мамандандырылған формулалар қолжетімді.

Торикалық ИОЛ-дарды есептеуге арналған кіріктірілген құралдар биометриялық және кератометриялық деректерді барлық көрсеткіштерді сыртқы калькуляторларға қолмен көшірмей-ақ, тікелей жүйе ішінде пайдалануға мүмкіндік береді.

ZEISS жүйелері үшін катаракта бойынша 50 000-нан астам операция деректері негізінде қалыптасқан ИОЛ-дың 300-ден астам моделіне арналған оңтайландырылған константалар қолжетімді.

Рефракциялық хирургиядан кейінгі көздер

LASIK, PRK немесе LASEK-тен кейін қасаң қабық пішінінің өзгеруі ИОЛ есептеуді қиындатады, өйткені стандартты кератометриялық жорамалдар азырақ дәл болуы мүмкін.

ZEISS IOLMaster® 700 мұндай жағдайлар үшін арнайы құралдарды ұсынады, соның ішінде:

• Haigis-L;
• Barrett True K;
• Barrett True K with TK;
• үйлесімді формулаларда Total Keratometry қолдану.

Barrett True K with TK формуласы қасаң қабықтың артқы бетін жеке өлшейтін Total Keratometry деректерін пайдаланады.

Миопиялық LASIK-тен кейінгі көздерге жүргізілген жарияланған зерттеуде, классикалық кератометриясы бар Barrett True K-мен салыстырғанда Barrett True K with TK қолданғанда ±0,50 D шегіндегі нәтижелер үлесі 12 пайыздық тармақтан астамға жоғары болды.

SMILE процедурасынан кейінгі пациенттер үшін формуланы таңдау ағымдағы пайдалану жөніндегі нұсқаулыққа және клиникалық жағдайға сәйкес жүзеге асырылуы тиіс. ZEISS-тің қолданыстағы құжаттамасы LASIK, LASEK және PRK-ға арналған стандартты рефракциядан кейінгі формулаларды мұндай көздерге автоматты түрде қолдануды ұсынбайды.

Визуализация және фиксацияны бақылау

Swept Source OCT қасаң қабықтан торлы қабыққа дейін көздің бойлық кескінін қалыптастырады.

OCT-қимасында дәрігер анатомиялық құрылымдар мен өлшеу шекараларының орналасуын көре алады. Бұл келесіге көмектеседі:

• биометриялық өлшеудің дұрыстығын бақылауға;
• көздің ерекше геометриясын анықтауға;
• көз бұршағының орналасуын және ықтимал қисаюын бағалауға;
• пациенттің фиксация сапасын бақылауға.

Макуланың орталық аймағы мен фовеалық шұңқырдың кескіні фиксацияны қосымша бақылау ретінде пайдаланылады. Егер фиксация жеткіліксіз болса, деректерді ИОЛ есептеу үшін пайдаланғанға дейін өлшеуді қайталауға болады.

Операциялық бөлмеге интеграциялау

Биометрия кезінде IOLMaster® 700 ZEISS-тің белгісіз хирургиялық жұмыс процесі үшін көздің референттік кескінін ала алады.

Референттік кескін мен кератометриялық деректерді ZEISS CALLISTO eye жүйесіне беруге болады және оларды операциядан бұрынғы кескінді операция кезіндегі көздің орналасуымен, соның ішінде торикалық ИОЛ-дарды орналастыру кезінде сәйкестендіру үшін пайдалануға болады.

ZEISS VERACITY Surgery Planner-мен интеграция биометриялық көрсеткіштер мен диагностикалық материалдарды беруге мүмкіндік береді, соның ішінде:

• анатомияны және ықтимал өзгерістерді бағалауға арналған OCT-кескіні;
• интраоперациялық навигацияға арналған референттік кескін;
• Total Keratometry үшін қасаң қабықтың артқы бетінің деректері;
• кератометриялық және басқа биометриялық көрсеткіштер.

Технологиялар мен функционал

Swept Source OCT

IOLMaster® 700 орталық толқын ұзындығы шамамен 1055 нм болатын Swept Source OCT пайдаланады.

Жүйе секундына шамамен 2 000 A-скан жылдамдығымен жұмыс істейді және алты меридиан бойынша кескіндерді алады:

• 0°;
• 30°;
• 60°;
• 90°;
• 120°;
• 150°.

Бойлық Cornea-to-Retina Scan қасаң қабықтан торлы қабыққа дейінгі көзді визуализациялауға мүмкіндік береді.

Тек A-скан пиктерін дәстүрлі көрсеткіштен айырмашылығы, жүйе анатомиялық құрылымдардың OCT-кескінін және өлшеу шекараларын көрсетеді, бұл операторға өлшеудің дұрыстығын визуалды түрде бағалауға мүмкіндік береді.

ZEISS деректері бойынша, бұл технология катаракта кезінде 99%-ға дейін өту қабілетін (penetration rate) қамтамасыз етеді, бұл осьтік ұзындықты өлшеу үшін ультрадыбыстық биометрияға көшу қажет болатын жағдайлар санын азайтады.

Total Keratometry (TK®)

Total Keratometry мыналарды біріктіреді:

• қасаң қабықтың алдыңғы бетінің телецентристік кератометриясы;
• Swept Source OCT көмегімен қасаң қабықтың артқы бетін өлшеу;
• қасаң қабықтың қалыңдығы туралы деректер.

Нәтижесінде жүйе тек алдыңғы және артқы беттер арасындағы модельдік қатынысқа сүйенбей, қасаң қабықтың екі бетінің де жеке геометриясын ескере отырып, толық кератометрияны есептейді.

Total Keratometry үшін мамандандырылған формулалар қолжетімді:

• Barrett TK Universal II;
• Barrett TK Toric;
• Barrett True K with TK.

TK мәндерін бағдарламалық қамтамасыз ету нұсқаулығына сәйкес бірқатар стандартты ИОЛ есептеу формулаларымен де пайдалануға болады.

Телецентристік кератометрия

Қасаң қабықтың алдыңғы беті телецентристік кератометрия әдісімен өлшенеді.

Жүйе үш өлшеу аймағында орналасқан 18 жарықдиодты нүктенің шағылысуын талдайды.

Телецентристік принцип нәтиженің аспап пен көз арасындағы жұмыс қашықтығына тәуелділігін азайтады және кератометриялық өлшеулердің қайталанбалылығына ықпал етеді.

Фиксацияны бақылау

IOLMaster® 700 биометрия кезінде пациенттің қарау бағытын бақылау үшін макулярлық орталық аймақтың OCT-кескінін пайдаланады.

Фовеалық шұңқырдың бейнеленуі операторға өлшеудің дұрыс фиксациямен орындалғанын бағалауға көмектеседі.

Көздің орналасуы күмән тудырған жағдайда, биометриялық деректерді ИОЛ есептеу үшін қабылдағанға дейін өлшеуді қайталауға болады.

Central Topography

Central Topography стандартты биометрия процесі шеңберінде қасаң қабықтың орталық бөлігінің пішіні туралы ақпаратты ұсынады.

Бұл функция бөлек диагностикалық аспапты немесе қосымша сканерлеуді талап етпейді және ИОЛ таңдағанға дейін қасаң қабықтың орталық геометриясы туралы қосымша ақпарат алуға мүмкіндік береді.

Central Topography мұндай зерттеу клиникалық көрсеткіштер бойынша қажет болған кезде полноценды мамандандырылған қасаң қабық топографиясын немесе томографиясын алмастырмайды.

Haigis Suite

Haigis Suite Haigis тұқымдасының бірнеше есептеу шешімдерін біріктіреді.

Клиникалық жағдайға және орнатылған бағдарламалық қамтамасыз ету нұсқасына байланысты мыналар қолданылады:

• стандартты ИОЛ есептеуге арналған Haigis;
• LASIK, LASEK немесе PRK-дан кейінгі белгілі бір көздер үшін Haigis-L;
• торикалық ИОЛ есептеуге арналған Haigis-T;
• бағдарламалық қамтамасыз етудің ағымдағы нұсқасына және пайдалану жөніндегі нұсқаулыққа сәйкес формулалардың қосымша нұсқалары.

Техникалық сипаттамалары

• Түрі: Swept Source OCT негізіндегі жанаспайтын оптикалық биометр.
• OCT орталық толқын ұзындығы: шамамен 1055 нм.
• OCT сканерлеу жылдамдығы: секундына шамамен 2 000 A-скан.
• OCT сканерлеу схемасы: 30° қадаммен алты меридиан.
• Осьтік ұзындықты өлшеу диапазоны: 14–38 мм.
• Қасаң қабықтың қисықтық радиустар диапазоны: 5–11 мм.
• Алдыңғы камера тереңдігі: 0,7–8 мм.
• Көз бұршағының қалыңдығы: факикалық көз үшін 1–10 мм.
• Жасанды көз бұршағының қалыңдығы: псевдофакикалық көз үшін 0,13–2,5 мм.
• Орталық қасаң қабық қалыңдығы: 0,2–1,2 мм.
• White-to-white: 8–16 мм.
• Кератометрия: 18 жарықдиодты нүктенің шағылысуы бойынша телецентристік, үш аймақтық.
• Total Keratometry: орталық қасаң қабық қалыңдығын ескере отырып, қасаң қабықтың алдыңғы және артқы беттерін өлшеу.
• Зерттеу әдісі: жанаспайтын.
• Интеграция: ZEISS VERACITY Surgery Planner, ZEISS FORUM, ZEISS CALLISTO eye, ZEISS EQ Workplace және конфигурацияға байланысты басқа үйлесімді жүйелер.

Артықшылықтары

Дәрігер мен клиника үшін

• бір платформада негізгі биометриялық өлшеулердің толық жиынтығы;
• OCT-қимасында анатомиялық құрылымдар мен өлшеу шекараларын визуалды бақылау;
• Total Keratometry көмегімен қасаң қабықтың артқы бетін жеке өлшеу;
• түрлі клиникалық міндеттерге арналған кіріктірілген Barrett және Haigis формулалары;
• торикалық ИОЛ-дарды есептеу құралдары;
• макуланың орталық аймағының кескіні бойынша фиксацияны бақылау;
• стандартты биометриялық жұмыс процесіндегі Central Topography;
• CALLISTO eye жүйесімен интеграциялау кезінде торикалық ИОЛ-дарды белгісіз орталықтандыруға арналған референттік кескін;
• ZEISS экожүйесінде цифрлық деректерді беру;
• ИОЛ-дың 300-ден астам моделі үшін оңтайландырылған константаларға қол жеткізу.

Пациент үшін

• зерттеу жанаспай жүргізіледі;
• стандартты оптикалық биометрия үшін анестезиялайтын тамшылар қажет емес;
• екі көзді өлшеу 45 секундтан аз уақытты алуы мүмкін;
• Swept Source OCT оптикалық биометрлердің алдыңғы буындары үшін жеткіліксіз болуы мүмкін көптеген тығыз катаракталар кезінде оптикалық биометрияны орындауға мүмкіндік береді;
• ИОЛ есептеу үшін қажетті параметрлердің көпшілігі бір диагностикалық процесс шеңберінде алынады.

ZEISS MEL 90

The ZEISS MEL 90 is an excimer laser designed for corneal ablation in refractive surgery. The system features FLEXIQUENCE for switching between 250 Hz and 500 Hz, the Triple-A ablation algorithm and an ablation speed of up to 1.3 seconds per diopter under specified myopic LASIK treatment conditions.

Manufacturer

Carl Zeiss Meditec AG, Jena, Germany.

ZEISS has been using excimer laser technology in refractive surgery since 1986.

Regulatory status:

• CE marked in accordance with Regulation (EU) 2017/745 on medical devices;
• Availability of individual functions and treatment modes depends on local regulatory requirements.

Applications

Refractive ablation

The ZEISS MEL 90 is used for the excimer laser ablation stage of procedures including Femto-LASIK, PRK and LASEK. The laser reshapes the cornea through controlled tissue ablation to correct myopia, hyperopia and astigmatism.

For primary LASIK, the FDA-approved indications for the MEL 90 include:

• Myopia: sphere less in magnitude than −10.00 D, with or without cylinder up to −4.00 D, when MRSE is less in magnitude than −10.00 D;
• Hyperopia: sphere up to +4.00 D, with or without cylinder up to +3.00 D, when MRSE is up to +5.00 D;
• Mixed astigmatism: cylinder greater than 1.00 D and up to 4.00 D;
• Patient age: 18 years or older;
• Change in manifest refraction spherical equivalent during the preceding year: no more than ±0.50 D.

Indication ranges and availability of specific procedures may vary by country, software version and the applicable instructions for use.

Presbyopia correction – PRESBYOND Laser Blended Vision

PRESBYOND Laser Blended Vision is an optional software-based LASIK treatment approach for presbyopia.

Treatment planning takes into account:

• Preoperative spherical aberrations;
• Ocular dominance;
• The result of an anisometropia tolerance test of approximately 1.5 D;
• Functional age of the eyes.

The technology generates an individualized nonlinear aspheric ablation profile and increases the depth of focus of each eye. Combined with micro-anisometropia, this produces an overlapping range of vision known as the Blend Zone, supporting functional distance, intermediate and near vision.

Phototherapeutic keratectomy (PTK)

The system supports phototherapeutic keratectomy with area ablation and PTK shaping. Availability of PTK depends on the regulatory status of the system in the respective market.

Technology and features

FLEXIQUENCE – 250 Hz / 500 Hz switching

FLEXIQUENCE allows the laser repetition rate to be switched between 250 Hz and 500 Hz. The operating mode is selected according to the treatment parameters and system configuration.

FLEXIQUENCE is not available in every market. In particular, the switchable 250/500 Hz configuration is not available on the U.S. version of the MEL 90.

Triple-A Advanced Ablation Algorithm

Triple-A is a single ablation algorithm designed for a broad range of sphero-cylindrical corrections. Its aspherically optimized profile combines treatment geometry with intelligent energy correction.

The algorithm is designed to generate the planned corneal profile accurately while using corneal tissue efficiently. A single algorithm also simplifies planning across different spherical and cylindrical corrections.

Ablation speed

When performing LASIK for myopia at 500 Hz, the ZEISS MEL 90 can ablate one diopter in approximately 1.3 seconds. This value is specified for a 6 mm optical zone.

Actual laser treatment time depends on the amount of refractive correction, the selected ablation profile and the parameters of the individual procedure.

Active eye tracker

The integrated infrared eye tracker monitors the pupil and limbus at 1050 frames per second.

The system supports:

• Automatic Pupil Center Shift Correction;
• Manual selection of the ablation center;
• Continuous monitoring of eye position during laser treatment.

This allows the system to account for eye movements and maintain the intended positioning of the ablation zone.

CCA+ system

CCA+ is an integrated plume removal system that removes ablation products from the treatment area. In the relevant system configuration, it adapts automatically to 250 Hz and 500 Hz operation.

The system helps maintain stable atmospheric conditions immediately above the ocular surface during laser ablation.

Visualization and controls

The ZEISS MEL 90 is equipped with an OPMI pico surgical microscope with an integrated HD video camera.

The illumination system includes:

• Ring illumination with stepless adjustment;
• Sectional light;
• Satellite illumination;
• Optional slit-lamp illumination.

The system is operated through a graphical interface using a touchscreen or keyboard. The position of the display can be adjusted to suit the surgeon's working position.

An optional second workstation can be provided for an assistant. Laser calibration is performed using the fluence test.

Integration into the ZEISS ecosystem

The ZEISS MEL 90 can be integrated with other components of the ZEISS refractive ecosystem.

ZEISS Refractive Workplace, together with FORUM, enables digital treatment planning outside the operating room and transfers completed treatment plans directly to the MEL 90 and VISUMAX 800.

The ecosystem can also incorporate:

• ATLAS 500 for corneal topography;
• VISULYZE for outcome analysis and nomogram management;
• HD video output;
• Network printer connectivity;
• PDF export.

When used together with the VISUMAX 800, a shared patient support configuration can facilitate the transition between the femtosecond and excimer laser stages of treatment.

Technical specifications

• Type: ArF excimer laser.
• Wavelength: 193 nm.
• Main laser class: Class 4 according to IEC 60825-1:2014.
• Fixation laser: solid-state laser.
• Fixation laser wavelength: 532 nm.
• Fixation laser class: Class 1 according to IEC 60825-1:2014.
• Repetition rate: FLEXIQUENCE 250 Hz / 500 Hz in the applicable international configuration.
• Beam profile: Gaussian.
• Beam diameter: 0.7 mm FWHM.
• Gas supply: integrated 10 L ArF-Premix cylinder for the international configuration.
• Dimensions (W × D × H): 1.63 × 0.73 × 1.48–1.70 m.
• Laser system weight: 295 kg with gas cylinder.
• Patient support system weight: 232 kg.
• Power supply: 100 V AC / 17.5 A; 120 V AC / 14.6 A; 208, 220, 230 or 240 V AC / 7.9 A; 50/60 Hz.
• Regulatory status of the international version: CE marked in accordance with Regulation (EU) 2017/745.

Benefits

For the surgeon and clinic

• Ablation speed of up to 1.3 seconds per diopter during myopic LASIK at 500 Hz with a 6 mm optical zone;
• FLEXIQUENCE switching between 250 Hz and 500 Hz in applicable configurations;
• A single Triple-A algorithm for a broad range of sphero-cylindrical corrections;
• Active eye tracking at 1050 frames per second;
• Integrated CCA+ plume removal system;
• Low service maintenance requirements;
• Beam path evacuation eliminates the need for additional flushing gas;
• Digital treatment planning and data exchange within the ZEISS ecosystem.

For the patient

• Short time directly under the excimer laser;
• Aspherically optimized Triple-A profile designed for efficient use of corneal tissue;
• Active monitoring of eye position during ablation;
• Patient support system designed to maintain stable positioning during treatment;
• PRESBYOND provides a corneal laser option for presbyopia without replacing the natural crystalline lens in appropriately selected patients.

ZEISS OPMI LUMERA® i Ophthalmic Surgical Microscope

Overview

The ZEISS OPMI LUMERA® i is a surgical microscope designed for anterior and posterior segment ophthalmic surgery. The system combines ZEISS apochromatic optics with Stereo Coaxial Illumination (SCI), which provides a stable, high-contrast red reflex during ophthalmic procedures.

Depending on its configuration, the microscope can be used with ZEISS RESIGHT® 500, CALLISTO eye and the External Data Injection System (EDIS).

Manufacturer

Carl Zeiss Meditec AG, Germany.

Applications

Cataract surgery

Stereo Coaxial Illumination provides a bright and stable red reflex that helps the surgeon distinguish anterior segment structures.

According to ZEISS, SCI can provide a red reflex even in mature cataracts. This supports visualization during surgical steps including:

• capsulorhexis;
• removal of lens material;
• IOL implantation and positioning.

When integrated with ZEISS CALLISTO eye and EDIS, additional visual guidance for capsulorhexis, IOL centration and toric IOL alignment can be displayed directly in the eyepiece.

Vitreoretinal surgery

When combined with the non-contact ZEISS RESIGHT® 500 fundus viewing system, the microscope provides detailed retinal visualization during vitreoretinal procedures.

RESIGHT® 500 uses Varioscope optics to maintain retinal focus without repositioning the microscope head. Its lens system includes:

• a 128 D wide-field lens for peripheral retinal visualization;
• a 60 D lens for higher-magnification visualization of the macular region.

An optional Invertertube® is also available for the OPMI LUMERA® i. Image inversion is integrated directly into the binocular tube, reducing the amount of equipment reconfiguration required when moving between anterior and posterior segment procedures.

Glaucoma surgery

The OPMI LUMERA® i can provide magnification and illumination of the surgical field during anterior segment procedures, including glaucoma surgery.

Apochromatic optics, adjustable illumination and depth-of-field management support visualization of small anatomical structures during precise microsurgical maneuvers.

Corneal surgery

The microscope can be used to visualize corneal structures during microsurgical procedures including keratoplasty.

When integrated with CALLISTO eye, EDIS can display additional guidance information in the eyepiece. K TRACK® enables visualization of corneal curvature in combination with a keratoscope and can be used, for example, during corneal transplantation.

Technology and features

Stereo Coaxial Illumination

Stereo Coaxial Illumination is designed to generate the red reflex during ophthalmic surgery.

The technology provides:

• a stable, high-contrast red reflex;
• clear visualization of ocular structure contours;
• separate adjustment of red reflex and full-field illumination.

According to ZEISS, SCI requires comparatively little light to generate the red reflex.

DeepView

DeepView is an integrated depth-of-field management system.

The surgeon can select between two priorities:

• maximum depth of field;
• optimum light transmission.

The setting can be changed through the microscope controls without manually reconfiguring the optical system.

Apochromatic optics and motorized zoom

The OPMI LUMERA® i incorporates ZEISS apochromatic optics.

Key parameters include:

• motorized 1:6 zoom system;
• magnification factors γ = 0.4 to 2.4;
• 50 mm focusing range;
• standard f = 200 mm objective lens;
• optional f = 175 mm objective lens;
• standard 10× eyepieces;
• optional 12.5× eyepieces;
• 0–180° tiltable binocular tube;
• optional Invertertube®.

This configuration allows magnification, focus and working position to be adjusted according to the surgical stage.

Eyepiece overlays – EDIS

The External Data Injection System is designed to display assistance information directly in the microscope eyepiece.

When the OPMI LUMERA® i is integrated with ZEISS CALLISTO eye, the surgeon can view high-contrast digital overlays for different cataract surgery steps, including:

• Incision / LRI Assistant;
• Rhexis Assistant;
• Z ALIGN® for toric IOL alignment;
• K TRACK®.

Depending on configuration, assistance functions can be controlled with the foot control panel, allowing the surgeon to remain focused through the eyepieces.

Protective filters

The illumination system includes:

• an integrated 408 nm UV barrier filter;
• a blue-blocking filter;
• a retinal protection device;
• fiber-optic illumination.

A fluorescence filter is available as an option.

Controls and observation

Primary microscope functions can be controlled using programmable controls and a foot control panel.

Controllable parameters include:

• X-Y positioning;
• focus;
• zoom;
• illumination.

When integrated with ZEISS CALLISTO eye, EDIS assistance functions can be controlled without requiring the surgeon to look away from the eyepieces.

Compatible ZEISS HD camera systems are available for video documentation. Depending on the installed configuration, images and recordings can be displayed on an external monitor or within the CALLISTO eye environment.

The optional Invertertube® incorporates the image inversion function and is designed to support an upright working posture.

Technical specifications

• Type: ophthalmic surgical microscope.
• Optics: apochromatic.
• Zoom: motorized.
• Zoom ratio: 1:6.
• Magnification factors: γ = 0.4–2.4.
• Focusing range: 50 mm.
• Objective lens: f = 200 mm.
• Optional objective: f = 175 mm.
• Eyepieces: 10×.
• Optional eyepieces: 12.5×.
• Binocular tube: 0–180° tiltable.
• Optional: Invertertube®.
• Depth of field: DeepView management system.
• Illumination: Stereo Coaxial Illumination.
• Red reflex illumination: adjustable.
• Full-field illumination: adjustable.
• UV filter: integrated 408 nm UV barrier filter.
• Additional protection: blue-blocking filter and retinal protection device.
• Light source: 12 V, 100 W halogen lamp with automatic changeover in case of lamp failure.
• X-Y adjustment range: 61 × 61 mm.
• Microscope head weight: approximately 8.5 kg without tube, objective lens and eyepieces.
• Suspension system: floor stand.
• Maximum stand load: 14 kg including microscope equipment and accessories.
• Video system: compatible ZEISS HD camera systems depending on configuration.

Benefits

For the surgeon and OR

• stable, high-contrast red reflex with SCI;
• red reflex visualization even with mature cataracts;
• independent adjustment of red reflex and full-field illumination;
• depth-of-field management with DeepView;
• apochromatic optics and motorized 1:6 zoom;
• integration with ZEISS RESIGHT® 500 for vitreoretinal surgery;
• optional Invertertube® reduces reconfiguration when transitioning between anterior and posterior segment procedures;
• assistance overlays displayed in the eyepiece through EDIS when integrated with CALLISTO eye;
• selected functions can be controlled from the foot control panel.

For the patient

• the illumination system incorporates a UV barrier filter, blue-blocking filter and retinal protection device;
• SCI requires comparatively little light to generate the red reflex;
• apochromatic optics and adjustable depth of field provide the surgeon with detailed visualization of ocular structures during microsurgical maneuvers.

ZEISS VisuMax

The ZEISS VisuMax is a femtosecond laser system designed for corneal surgery. The platform is used in refractive surgery, keratoplasty and the creation of tunnels for intracorneal ring segments. Systems from the ZEISS VisuMax family are used to perform ZEISS SMILE, a laser vision correction procedure that does not require the creation of a corneal flap.

Manufacturer

ZEISS (Carl Zeiss Meditec AG), Germany.

The company's core areas include:

• high-precision optics;
• optoelectronics;
• diagnostic and surgical equipment for ophthalmology.

Applications

ZEISS SMILE (ReLEx SMILE)

The femtosecond laser creates a refractive lenticule within the corneal stroma. The surgeon then removes the lenticule through a small incision. The procedure does not require the creation of a corneal flap.

According to ZEISS, an incision of approximately 2 mm is sufficient for SMILE. Most of the upper corneal layers remain untouched, while the lamellar incision area is approximately one third smaller than with Femto-LASIK.

Femto-LASIK

The ZEISS VisuMax can create a corneal flap with individually defined parameters, including:

• diameter;
• thickness;
• hinge position;
• side-cut angle.

After flap creation, refractive ablation is performed with an excimer laser, such as the ZEISS MEL 90. Within the ZEISS excimer laser workflow, PRESBYOND Laser Blended Vision can also be used for presbyopia correction.

Keratoplasty

The system can create precise lamellar and circular incisions for preparing donor and recipient corneal tissue.

Supported procedures include:

• penetrating keratoplasty (PKP);
• deep anterior lamellar keratoplasty (DALK);
• Descemet's stripping endothelial keratoplasty (DSEK).

The dedicated keratoplasty adapter provides a stable, sterile work surface for graft preparation. A specially designed curved type KP contact glass helps prevent unnecessary compression of corneal tissue.

Intracorneal ring segments

The ZEISS VisuMax can create stromal tunnels for the implantation of intracorneal rings and ring segments. Different incision parameters and geometries can be configured, including inclined and partial segment geometries.

Technology and features

High-frequency femtosecond laser delivery

The ZEISS VisuMax operates at a laser pulse rate of 500 kHz. High-precision ZEISS optics focus the laser beam into a small spot within the cornea, allowing incisions to be created at a predefined depth using low pulse energy.

The system supports three-dimensional curved incision profiles for different refractive and therapeutic corneal procedures.

Curved contact glasses S, M, L

ZEISS VisuMax contact glasses are curved to follow the anatomical curvature of the cornea. Three sizes are available: S, M and L.

This design allows the cornea to largely retain its natural physiological shape during docking and helps avoid unnecessarily elevated intraocular pressure and cutting artifacts.

The contact glass is secured to the eye using controlled suction. Each contact glass is individually measured during the system test, after which the VisuMax automatically calibrates for accurate laser spot positioning.

Surgical microscope and slit illumination

The system incorporates a ZEISS surgical microscope with a video camera and digital recording. This enables the surgeon to monitor the different stages of the procedure directly from the system.

Additional slit illumination allows the cornea to be assessed immediately after the laser step without moving the patient.

Pivoting patient support system

The ZEISS VisuMax includes a pivoting patient support system. When the platform is combined with the ZEISS MEL 90 excimer laser, the patient can remain on the same support system while transitioning between treatment stages.

This configuration simplifies the workflow for combined refractive procedures and eliminates the need to move the patient between separate treatment stages.

Controls

The system uses a cockpit-style layout that keeps the primary controls within easy reach of the surgeon.

An interactive touchscreen and dedicated software support treatment parameter entry and guide the surgeon through the individual procedural steps.

Technical specifications

• Type: femtosecond laser for corneal surgery.
• Wavelength: 1043 nm.
• Pulse duration: 220–580 fs.
• Laser pulse rate: 500 kHz.
• Contact glasses: curved, sizes S, M and L.
• Keratoplasty contact glass: type KP.
• Incision geometry: three-dimensional curved profiles at a predefined depth.
• Visualization: ZEISS surgical microscope, video camera with digital recording and slit illumination.
• Integration: pivoting patient support system for use in combination with the ZEISS MEL 90 excimer laser.

Benefits

For the surgeon and clinic

• capability to perform ZEISS SMILE;
• one system for lenticule creation, corneal flap creation, keratoplasty incisions and tunnels for intracorneal ring segments;
• 500 kHz pulse rate supports short laser treatment times;
• integrated surgical microscope, video camera and slit illumination;
• immediate corneal assessment after the laser step without moving the patient;
• integration with the ZEISS MEL 90 excimer laser.

For the patient

• SMILE vision correction without creating a corneal flap;
• small incision with ZEISS SMILE;
• curved contact glass helps maintain the cornea's natural shape during docking;
• interface design helps avoid unnecessarily elevated intraocular pressure;
• when VisuMax and MEL 90 are used together, the patient does not need to be transferred between treatment stages.