Impact of Color Correcting Lenses on Color Vision Deficiency
Study Details
Study Description
Brief Summary
To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Color Vision Deficient with Color Correcting Lenses 10 subjects confirmed to have hereditary color vision deficiency randomly assigned to experimental group 1 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses. |
Device: Experimental Group 1: Color Correcting Lenses
Color Correcting Lenses
|
| Placebo Comparator: Color Vision Deficient with Placebo Lenses 10 subjects confirmed to have hereditary color vision deficiency randomly assigned to Placebo Group 1 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses. |
Device: Placebo Group 1: Placebo Lenses
Placebo Lenses
|
| Experimental: Crossover: Placebo to Experimental Placebo Group 1 crosses over to become Experimental Group 2 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses. |
Device: Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses
Color Correcting Lenses
|
| Placebo Comparator: Crossover: Experimental to Placebo Experimental Group 1 crosses over to become Placebo Group 2 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses. |
Device: Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses
Placebo Lenses
|
| Active Comparator: Control Group: Subjects with Normal Color Vision Fifteen subjects confirmed to have normal color vision will be tested in a single session to determine whether color correcting lenses affect color vision in color vision normal subjects and to provided normative data for several unique measures of color vision performance |
Device: Color Correcting Lenses in Subjects with Normal Color Vision
Color Correcting Lenses
|
Outcome Measures
Primary Outcome Measures
- Cone Contrast Test [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 [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 [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.
- Color Matching [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.
- Color Identification Test [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.
- Visual Electrodiagnostic Testing [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of the Incarnate Word Rosenberg School of Optometry | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- University of the Incarnate Word
- National Eye Institute (NEI)
Investigators
- Principal Investigator: Jeffrey Rabin, C
Study Documents (Full-Text)
More Information
Publications
- Cole BL, Maddocks JD. Color vision testing by Farnsworth lantern and ability to identify approach-path signal colors. Aviat Space Environ Med. 2008 Jun;79(6):585-90.
- Rabin J, Gooch J, Ivan D. Rapid quantification of color vision: the cone contrast test. Invest Ophthalmol Vis Sci. 2011 Feb 9;52(2):816-20. doi: 10.1167/iovs.10-6283.
- Rabin J, Kryder A, Lam D. Binocular facilitation of cone-specific visual evoked potentials in colour deficiency. Clin Exp Optom. 2018 Jan;101(1):69-72. doi: 10.1111/cxo.12567. Epub 2017 Jun 21.
- Rabin J, Silva F, Trevino N, Gillentine H, Li L, Inclan L, Anderson G, Lee E, Vo H. Performance enhancement in color deficiency with color-correcting lenses. Eye (Lond). 2022 Jul;36(7):1502-1503. doi: 10.1038/s41433-021-01924-0. Epub 2022 Jan 8.
- Rabin J. Cone-specific measures of human color vision. Invest Ophthalmol Vis Sci. 1996 Dec;37(13):2771-4.
- Rabin J. Quantification of color vision with cone contrast sensitivity. Vis Neurosci. 2004 May-Jun;21(3):483-5.
- Rabin JC, Kryder AC, Lam D. Diagnosis of Normal and Abnormal Color Vision with Cone-Specific VEPs. Transl Vis Sci Technol. 2016 May 17;5(3):8. eCollection 2016 May.
- Spalding JA, Cole BL, Mir FA. Advice for medical students and practitioners with colour vision deficiency: a website resource. Clin Exp Optom. 2010 Jan;93(1):39-41. doi: 10.1111/j.1444-0938.2009.00434.x. Epub 2009 Oct 27.
- Werner JS, Marsh-Armstrong B, Knoblauch K. Adaptive Changes in Color Vision from Long-Term Filter Usage in Anomalous but Not Normal Trichromacy. Curr Biol. 2020 Aug 3;30(15):3011-3015.e4. doi: 10.1016/j.cub.2020.05.054. Epub 2020 Jun 25.
- 2022-1194-EXP
- 1T35EY032441-01A1