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Completed

NCT Number: NCT05463016

Impact of Color Correcting Lenses on Color Vision Deficiency

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

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Key information

Conditions

Color Blindness Color Blindness, Green Color Blindness, Red Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Group 1: Color Correcting Lenses

Device

Color Correcting Lenses

Placebo Group 1: Placebo Lenses

Device

Placebo Lenses

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

Device

Color Correcting Lenses

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

Device

Placebo Lenses

Color Correcting Lenses in Subjects with Normal Color Vision

Device

Color Correcting Lenses

Primary outcomes

  1. Cone Contrast Test

    Time frame: 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.

  2. Cone Contrast Naming Test

    Time frame: 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.

  3. Letter Chart Testing

    Time frame: 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.

  4. Color Matching

    Time frame: 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.

  5. Color Identification Test

    Time frame: 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.

  6. Visual Electrodiagnostic Testing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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