Impact of Color Correcting Lenses on Color Vision Deficiency

Not Applicable

Completed

• Conditions: Color Blindness; Color Blindness, Green; Color Blindness, Red; Color Vision Defects
• Interventions: Device: Color Correcting Lenses in Subjects with Normal Color Vision

• Registration Number: NCT05463016
• Lead Sponsor: University of the Incarnate Word

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.

Study Timeline

• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2022-07-28
• Primary Completion: 2023-08-01
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group: Subjects with Normal Color Vision	Color Correcting Lenses in 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

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

University of the Incarnate Word Rosenberg School of Optometry; 🇺🇸 San Antonio, Texas, United States