Impact of Color Correcting Lenses on Color Vision Deficiency

University of the Incarnate Word35 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Experimental Group 1: Color Correcting LensesDEVICE

Color Correcting Lenses

Placebo Group 1: Placebo LensesDEVICE

Placebo Lenses

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

Color Correcting Lenses

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of the Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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