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ITrace Wavefront Aberrometer

ITrace Wavefront Aberrometer

Abstract

The Tracey Technologies iTrace is a 5-in-1 ophthalmic diagnostic platform combining patented sequential ray-tracing aberrometry (256 points at 655/785nm wavelengths) with Placido-disk topography (24 rings, 8,640 points), autorefraction (±15D sphere/±10D cylinder), keratometry, and pupillometry (2.5-8mm range), uniquely separating corneal from internal aberrations and featuring proprietary DLI™/CPI™/QVI™ indices, marker-free Toric IOL planning/verification, and no-dilation post-op assessment capabilities.

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 lensScale: 0-10 (objective grading)Used for cataract diagnosis and premium IOL candidacy
  2. **Corneal Performance Index (CPI™)**Quantifies vision loss attributed to the corneaScale: 0-10 (objective grading)Identifies corneal aberrations and irregularities
  3. **Quality of Vision Index (QVI™)**Combined total eye visual quality metricSum of corneal and lenticular contributionsComprehensive vision assessment tool
  4. **Tear Film Index (TFI)**Assesses ocular surface stabilityEvaluates pre-operative tear film qualityCritical 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 toric calculator using advanced iTrace keratometryPortable eye image maps for precise intraoperative lens alignmentUses natural iris landmarks for marker-free alignmentOptical alignment angle measurement
  • Toric Check (Post-Operative):NO DILATION REQUIRED - 30-second examinationDetermines if toric IOL is off-axis or off-powerCalculates predicted BCVA change with lens rotationProvides 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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