Impact of Color Correcting Lenses on Color Vision Deficiency

NCT05463016 | Completed FDA Device

• 2 other identifiers: 2022-1194-EXP1T35EY032441-01A1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Color Blindness; Color Vision Defects; Color Blindness, Green; Color Blindness, Red

Keywords

Color-Correcting Lenses

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (5)

Color Vision Deficient with Color Correcting Lenses

EXPERIMENTAL

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 Vision Deficient with Placebo Lenses

PLACEBO COMPARATOR

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

Crossover: Placebo to Experimental

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

Crossover: Experimental to Placebo

PLACEBO COMPARATOR

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

Control Group: Subjects with Normal Color Vision

ACTIVE COMPARATOR

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

Interventions

Experimental Group 1: Color Correcting Lenses DEVICE

Color Correcting Lenses

Color Vision Deficient with Color Correcting Lenses

Placebo Group 1: Placebo Lenses DEVICE

Placebo Lenses

Color Vision Deficient with Placebo Lenses

Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses DEVICE

Color Correcting Lenses

Crossover: Placebo to Experimental

Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses DEVICE

Placebo Lenses

Crossover: Experimental to Placebo

Color Correcting Lenses in Subjects with Normal Color Vision DEVICE

Color Correcting Lenses

Control Group: Subjects with Normal Color Vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• reported use of sleep-inducing or wakefulness drugs

Sponsors & Collaborators

• University of the Incarnate Word: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of the Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

Location

Related 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.

  PMID: 18581942 BACKGROUND

• 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.

  PMID: 19863590 BACKGROUND

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

  PMID: 8977494 BACKGROUND

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

  PMID: 15518234 BACKGROUND

• 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.

  PMID: 21051721 BACKGROUND

• 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.

  PMID: 32589909 BACKGROUND

• 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.

  PMID: 27226932 BACKGROUND

• 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.

  PMID: 28636141 BACKGROUND

• 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.

  PMID: 34999724 BACKGROUND

MeSH Terms

Conditions

Color Vision Defects

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Rabin

  C

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind randomized crossover trial

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 18, 2022
• Study Start: July 28, 2022
• Primary Completion: August 1, 2023
• Study Completion: March 31, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)