Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Color Matching
Study Overview
Brief Summary
To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.
Detailed Description
The long term objective of this study is to extend upon research demonstrating improvements in color vision deficiencies (CVDs) while wearing color-correcting lenses (CCLs) and after wearing CCLs. Recordings of brainwaves and eye-waves will be made to assess the retina, optic nerve and brain in order to localize where adaptive changes in the visual system are occurring in response to wearing CCLs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •no reported history of eye, systemic or ocular disease
- •VA of 20/30 in each eye
- •hereditary color vision deficient (CVDs) verified by failing scores on the red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates)
- •color vision normal (CVNs) verified by passing red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates)
Exclusion Criteria
- •reported use of sleep-inducing or wakefulness drugs
Outcomes
Primary Outcomes
Color Matching
Time Frame: 2 Weeks
Cone specific color matching provides the contrast seen by the normal cone type which matches the contrast seen by the defective cone type in units of % Weber contrast. Values will be converted to Z-scores to compare to outcomes with other units.
Visual Electrodiagnostic Testing
Time Frame: 2 Weeks
Cone specific visual brainwaves (VEPs) and flash and pattern eye waves (ERGs) will be quantified in terms of amplitude in microvolts and latency in msec. Values will be converted to Z-scores to compare to outcomes with other units.
Color Identification Test
Time Frame: 2 Weeks
Cockpit color identification test measure reaction time in seconds and error rate to identify colored targets on a computer display. Values will be converted to Z-scores to compare to outcomes with other units.
Cone Contrast Test
Time Frame: 2 WeekS
Cone Contrast Sensitivity (CS) Test (CCT, Innova Systems, Inc.): red, green \& blue cone CS using 100-point scale based on log changes in CS. Values will be converted to Z-scores to compare to outcomes with other units.
Cone Contrast Naming Test
Time Frame: 2 Weeks
Red, green \& blue cone CS and color naming accuracy each based on 100-point scale. Values will be converted to Z-scores to compare to outcomes with other units.
Letter Chart Testing
Time Frame: 2 Weeks
Letter chart cone specific VA, small letter CS, and large letter CS scored as number of letters correct with VA expressed as log MAR \& CS as log CS. Values will be converted to Z-scores to compare to outcomes with other units.
Secondary Outcomes
No secondary outcomes reported
Investigators
JEFFREY CARL RABIN
Professor
University of the Incarnate Word