Impact of Color Correcting Lenses on Color Vision Deficiency
NCT ID: NCT05463016
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-07-28
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
Experimental Group 1: Color Correcting Lenses
Color Correcting Lenses
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.
Placebo Group 1: Placebo Lenses
Placebo Lenses
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.
Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses
Color Correcting Lenses
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.
Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses
Placebo Lenses
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
Color Correcting Lenses in Subjects with Normal Color Vision
Color Correcting Lenses
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
University of the Incarnate Word
OTHER
Responsible Party
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JEFFREY CARL RABIN
Professor
Principal Investigators
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Jeffrey Rabin
Role: PRINCIPAL_INVESTIGATOR
C
Locations
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University of the Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, United States
Countries
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References
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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.
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.
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. doi: 10.1017/s0952523804213128.
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.
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.
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.
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. No abstract available.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2022-1194-EXP
Identifier Type: -
Identifier Source: org_study_id
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