Impact of Color Correcting Lenses on Color Vision Deficiency

University of the Incarnate Word

Status: Completed

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

Treatments: Device: Experimental Group 1: Color Correcting Lenses; Device: Placebo Group 1: Placebo Lenses; Device: Color Correcting Lenses in Subjects with Normal Color Vision; Device: Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses; Device: Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05463016

1T35EY032441-01A1 (U.S. NIH Grant/Contract)

2022-1194-EXP

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 5 patient groups, including a placebo group

Color Vision Deficient with Color Correcting Lenses

Experimental group

Description:

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.

Treatment:

Device: Experimental Group 1: Color Correcting Lenses

Color Vision Deficient with Placebo Lenses

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Group 1: Placebo Lenses

Crossover: Placebo to Experimental

Experimental group

Description:

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.

Treatment:

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

Crossover: Experimental to Placebo

Placebo Comparator group

Description:

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.

Treatment:

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

Control Group: Subjects with Normal Color Vision

Active Comparator group

Description:

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

Treatment:

Device: Color Correcting Lenses in Subjects with Normal Color Vision