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Impact of Color Correcting Lenses on Color Vision Deficiency

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05463016
Enrollment
35
Registered
2022-07-18
Start date
2022-07-28
Completion date
2024-03-31
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Color-Correcting Lenses

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.

Interventions

DEVICEExperimental Group 1: Color Correcting Lenses

Color Correcting Lenses

DEVICEPlacebo Group 1: Placebo Lenses

Placebo Lenses

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

Color Correcting Lenses

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

Placebo Lenses

DEVICEColor Correcting Lenses in Subjects with Normal Color Vision

Color Correcting Lenses

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
University of the Incarnate Word
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Double blind randomized crossover trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cone Contrast Test2 WeekSCone 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 Test2 WeeksRed, 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 Testing2 WeeksLetter 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.
Color Matching2 WeeksCone 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.
Color Identification Test2 WeeksCockpit 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.
Visual Electrodiagnostic Testing2 WeeksCone 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026