DEVICE OVERVIEW

The iTrace is a 5-in-1 diagnostic ophthalmic system that combines wavefront aberrometry, corneal topography, autorefraction, keratometry, and pupillometry in a single integrated platform.

CORE TECHNOLOGY

Ray-Tracing Aberrometry

• Technology Type: Sequential ray-tracing (forward aberration measurement)

• Light Source: Near-infrared laser diode

• Wavelength: 655 nm (topography) and 785 nm (ray tracing aberrometry)

• Number of Measurement Points: 256 parallel laser beams projected sequentially

• Measurement Principle: Measures where each light ray lands on the retina and quantifies light energy transfer

• Unique Capability: Only aberrometer using forward ray-tracing (measures light going into the eye, not reflected back)

Corneal Topography

• Technology: Placido disk-based system (Vista format by EyeSys Vision)

• Number of Rings: 24 concentric rings

• Measured/Analyzed Points: 8,640 data points

• Corneal Coverage: 8 mm diameter on 42.5D sphere

• Dioptric Range: 33.75 to 61.36 D

TECHNICAL SPECIFICATIONS

Refraction Measurements

• Sphere Range: ±15.0 D

• Cylinder Range: ±10.0 D

• Measurement Accuracy: ±0.10 D

• Reproducibility: ±0.10 D

• Correlation with Manifest Refraction: T = 0.9925 (ranges -0.01 to -0.4 D)

Pupil Analysis

• Pupil Scan Size Range: 2.5 mm to 8.0 mm diameter

• Pupillometry: Automatic measurement under various lighting conditions

• Day/Night Vision Analysis: Pupil size tracking for photopic and mesopic conditions

Keratometry

• Measurement Type: Automated keratometry (flat and steep meridians)

• Based On: Combined corneal topography and wavefront data

• Applications: IOL calculations, toric lens planning, corneal power assessment

Aberration Analysis

• Lower-Order Aberrations (LOA): Sphere, cylinder, defocus

• Higher-Order Aberrations (HOA): Coma, trefoil, spherical aberration, secondary astigmatism, tetrafoil

• Zernike Polynomial Analysis: Complete wavefront decomposition

• Measurement Separation: Total, corneal, and internal (lenticular) aberrations analyzed separately

PHYSICAL SPECIFICATIONS

• Footprint Dimensions: 13.0 inches (33.0 cm) × 17.0 inches (43.2 cm)

• Weight: 27.4 lbs (12.4 kg / 20 kg depending on configuration)

• Portability: Compact, space-saving design suitable for clinical settings

• Capture Modes: Automatic and manual

CLINICAL ANALYSIS CAPABILITIES

Proprietary Indices (iTrace Prime Dashboard)

1. Dysfunctional Lens Index (DLI™)

   • Quantifies vision loss attributed to the crystalline lens

   • Scale: 0-10 (objective grading)

   • Used for cataract diagnosis and premium IOL candidacy

2. Corneal Performance Index (CPI™)

   • Quantifies vision loss attributed to the cornea

   • Scale: 0-10 (objective grading)

   • Identifies corneal aberrations and irregularities

3. Quality of Vision Index (QVI™)

   • Combined total eye visual quality metric

   • Sum of corneal and lenticular contributions

   • Comprehensive vision assessment tool

4. Tear Film Index (TFI)

   • Assesses ocular surface stability

   • Evaluates pre-operative tear film quality

   • Critical for refractive surgery screening

Visual Function Analysis

• Retinal Spot Diagram (RSD): Graphical representation of total refraction, aberrations, and point spread function

• Point Spread Function (PSF): Predicts retinal image quality

• Modulation Transfer Function (MTF): Contrast sensitivity analysis

• Multi-Zone Refraction Analysis: Refraction across different pupil zones

• Wavefront Maps: Color-coded aberration maps (values in microns)

SPECIALIZED CLINICAL FEATURES

Toric IOL Planning & Verification

• Toric Planner:

  • Integrated toric calculator using advanced iTrace keratometry

  • Portable eye image maps for precise intraoperative lens alignment

  • Uses natural iris landmarks for marker-free alignment

  • Optical alignment angle measurement

• Toric Check (Post-Operative):

  • NO DILATION REQUIRED - 30-second examination

  • Determines if toric IOL is off-axis or off-power

  • Calculates predicted BCVA change with lens rotation

  • Provides rotation recommendations

Premium IOL Candidacy Assessment

• Visual Axis Identification: Locates patient's visual axis relative to pupil center

• Optical System Alignment: Determines multifocal IOL compatibility

• Kappa Angle Measurement: Assesses distance between visual axis and limbus center

• Pre-screening Tool: Predicts which patients will benefit from premium lenses

Patient Education Tools

• Visual Simulation: Shows patients their actual vision vs. corrected vision

• Snellen E Simulation: Demonstrates blurred vs. clear vision with/without correction

• Toric vs. Standard IOL Comparison: Visual comparison for astigmatic patients

• Objective Metrics: DLI, CPI, QVI communicated in patient-friendly format

DATA PROCESSING & OUTPUT

Acquisition & Analysis

• Scan Time: Under 1 minute for complete profile

• Data Processing: Point-by-point sequential analysis

• Internal Optometer: Automatic patient alignment and accommodation control

• Fogging Range: +7D to -5D (eliminates accommodation)

• Fixation: Binocular and monocular open-field (reduces accommodation)

Integration & Connectivity

• DICOM Compliance: Full integration (Version 6.3+)

• Network Capability: Networkable system

• Worklist Import: Managed worklist reduces data entry errors

• Batch Processing: Batch saving and printing capabilities

• Report Generation: Comprehensive, easy-to-interpret printable reports

Measurement Capabilities

• Over-Spectacle Measurement: Can measure through spectacles

• Post-Operative Analysis: Functions through IOLs, contact lenses, after LASIK

• Highly Aberrated Eyes: Effective even with significant optical irregularities

• Pseudophakia: Accurate measurements in patients with IOLs

• Cataract Assessment: Can measure through early cataracts

CLINICAL APPLICATIONS

Refractive Surgery

• Pre-operative screening and planning

• LASIK/PRK candidate evaluation

• Post-operative outcomes assessment

• Identifying causes of post-operative visual complaints

• Wavefront-guided treatment planning

Cataract Surgery

• Dysfunctional Lens Syndrome diagnosis

• Premium IOL candidate selection (multifocal, toric, accommodating)

• IOL power calculation optimization

• Toric IOL axis planning and verification

• Post-operative lens position assessment

General Ophthalmology & Optometry

• Differential diagnosis of vision complaints

• Corneal disease monitoring (keratoconus, irregular astigmatism)

• Contact lens fitting optimization

• Second-opinion evaluations

• Progression tracking of lens and corneal dysfunction

Research Applications

• Clinical studies requiring precise optical measurements

• Aberration analysis in various patient populations

• IOL performance evaluation

• Normal population reference databases

SOFTWARE VERSIONS & UPGRADES

Current Version: iTrace 7.0 (iTrace Prime)

Key Features:

• Prime Dashboard (DLI, CPI, QVI indices)

• Enhanced imaging quality

• Improved wavefront capture process

• Enhanced navigation between displays

• Batch saving and printing

• Toric Planner customization improvements

• Tech Triage icon (quality control for technicians)

• Exam Results display (validates scan quality)

Previous Major Versions:

• Version 6.3: Added DICOM compliance

• Version 6.1: Introduced Toric Check feature

• Version 6.0: Introduced Dysfunctional Lens Index (DLI)

• Version 4.0: Made diagnostic aberrometry accessible to all physicians

Upgrade Policy: Existing iTrace owners can upgrade software to access latest features

MEASUREMENT ACCURACY & VALIDATION

Clinical Studies

• High concordance with manifest refraction (T = 0.9925)

• More accurate than Hartmann-Shack aberrometers in post-refractive surgery eyes

• Excellent repeatability for spherical aberration and multiple aberrometric coefficients

• Intraclass correlation coefficients (ICC) > 0.96 for angle kappa measurements

Repeatability

• Low within-subject standard deviation (Sw) for most measurements

• Coefficient of variation (COV) better for lower-order aberrations

• Repeatability affected by tear film quality (assess tear film before imaging)

Interdevice Comparisons

• Comparable to Pentacam, OPD-Scan, and other aberrometers for specific parameters

• Unique capability to separate corneal from internal aberrations

• Different measurement principles may yield non-interchangeable Zernike coefficients

COMPETITIVE ADVANTAGES

1. Only Ray-Tracing Aberrometer: Measures forward aberrations (how eye actually uses light)

2. Corneal vs. Internal Separation: Only device that mathematically separates corneal from lenticular aberrations

3. Post-Operative Capability: Accurate measurements through IOLs, contact lenses, after refractive surgery

4. No Dilation Toric Check: Unique post-operative toric assessment without dilation

5. 5-in-1 Integration: Eliminates need for multiple separate devices

6. Patient Education: Visual simulation capabilities for enhanced patient communication

7. Compact Footprint: Space-efficient design vs. multiple standalone devices

COMPATIBILITY & INTEGRATION

• Compatible with major EMR/EHR systems (via DICOM)

• Integrates with surgical planning software

• Exports data for IOL calculation programs

• Network-ready for multi-location practices

• Standalone computer included (HP Panel PC with Intel i5 processor)

CLINICAL VALIDATION & ADOPTION

• Used extensively in research institutions for clinical studies

• Adopted by thousands of ophthalmology and optometry practices worldwide

• Referenced in numerous peer-reviewed publications

• Standard of care for practices performing premium cataract surgery

• Endorsed by leading ophthalmologists for toric and multifocal IOL procedures

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