Impact of Color Correcting Lenses on Color Vision Deficiency

Color Vision Defects Clinical Trial

Official title:

Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463016
• Other study ID #: 2022-1194-EXP
• Secondary ID: 1T35EY032441-01A
• Status: Completed
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 31, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Color Blindness, Red
• Color Vision Defects

Intervention

Device:
• Experimental Group 1: Color Correcting Lenses
Color Correcting Lenses
• Placebo Group 1: Placebo Lenses
Placebo Lenses
• Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses
Color Correcting Lenses
• Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses
Placebo Lenses
• Color Correcting Lenses in Subjects with Normal Color Vision
Color Correcting Lenses

Locations

Country	Name	City	State
United States	University of the Incarnate Word Rosenberg School of Optometry	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of the Incarnate Word	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. doi: 10.3357/asem.2245.2008. — View Citation

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. — View Citation

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. — View Citation

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. No abstract available. — View Citation

Rabin J. Cone-specific measures of human color vision. Invest Ophthalmol Vis Sci. 1996 Dec;37(13):2771-4. — View Citation

Rabin J. Quantification of color vision with cone contrast sensitivity. Vis Neurosci. 2004 May-Jun;21(3):483-5. doi: 10.1017/s0952523804213128. — View Citation

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. doi: 10.1167/tvst.5.3.8. eCollection 2016 May. — View Citation

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. No abstract available. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cone Contrast Test	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.	2 WeekS
Primary	Cone Contrast Naming Test	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.	2 Weeks
Primary	Letter Chart Testing	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.	2 Weeks
Primary	Color Matching	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.	2 Weeks
Primary	Color Identification Test	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.	2 Weeks
Primary	Visual Electrodiagnostic Testing	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.	2 Weeks