Clinical trial NCT05463016: Impact of Color Correcting Lenses on Color Vision Deficiency
Official title: Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Color Blindness
Color Vision Defects
Color Blindness, Green
Color Blindness, Red
Keywords: Color-Correcting Lenses
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2022-07-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind randomized crossover trial
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Cone Contrast Test
timeFrame: 2 WeekS
measure: Cone Contrast Naming Test
timeFrame: 2 Weeks
measure: Letter Chart Testing
timeFrame: 2 Weeks
measure: Color Matching
timeFrame: 2 Weeks
measure: Color Identification Test
timeFrame: 2 Weeks
measure: Visual Electrodiagnostic Testing
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of the Incarnate Word Rosenberg School of Optometry
state: Texas
Study officials:
affiliation: C
name: Jeffrey Rabin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Rabin J. Cone-specific measures of human color vision. Invest Ophthalmol Vis Sci. 1996 Dec;37(13):2771-4.
citation: Rabin J. Quantification of color vision with cone contrast sensitivity. Vis Neurosci. 2004 May-Jun;21(3):483-5. doi: 10.1017/s0952523804213128.
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.
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.
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.
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.
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.