What side effects are associated with this type of intervention?

Color-correcting lenses, which alter wavelengths of light to enhance color discrimination, are a common treatment for color blindness. Known side effects of these lenses can include headaches, eye strain, and discomfort due to the altered perception of colors. Some users may also experience difficulty adjusting to the lenses, leading to temporary visual disturbances. It is important for patients to consult with their eye care provider to ensure proper fit and to monitor for any adverse effects.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for the treatment of color blindness in the provided context. However, the use of color-correcting lenses, which alter wavelengths of light to enhance color discrimination, is a noted approach to improve color vision in individuals with color vision deficiencies.

What other types of research exist?

Promising novel alternatives to color-correcting lenses for color blindness patients include: 1) Gene therapy, which aims to correct the genetic mutations causing color blindness; 2) Advanced optical devices, such as smart glasses with real-time color enhancement features; and 3) Digital solutions, including mobile apps and augmented reality (AR) systems that can modify color perception through digital filters.

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Color Correcting Lenses

Color Correcting Lenses for Color Blindness

N/A

Waitlist Available

Led By Jeffrey Rabin

Research Sponsored by University of the Incarnate Word

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

No reported history of eye, systemic or ocular disease

Must not have

Reported use of sleep-inducing or wakefulness drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Summary

This trial tests special glasses that help people with color vision problems see colors more accurately. It focuses on people who have trouble distinguishing colors. The glasses work by changing how colors look, making it easier for the brain and eyes to tell them apart.

Who is the study for?

This trial is for individuals with hereditary color vision deficiencies (CVDs) who have normal eye health and a visual acuity of at least 20/30. It's also open to those with normal color vision as controls. People using sleep or wakefulness drugs, or those with eye diseases are excluded.

What is being tested?

The study tests if wearing color-correcting lenses can improve the color vision in people with CVDs. Participants will be split into groups; some start with placebo lenses then switch to color-correcting ones, while others do the opposite.

What are the potential side effects?

Since this trial involves non-invasive lenses similar to regular contact lenses, side effects may include discomfort while wearing them, potential eye irritation or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed hereditary color vision deficiency.

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I have no history of eye or systemic diseases.

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My vision is at least 20/30 in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use medication to help me sleep or stay awake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Color Identification Test

Color Matching

Cone Contrast Naming Test

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Crossover: Placebo to ExperimentalExperimental Treatment1 Intervention

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.

Group II: Color Vision Deficient with Color Correcting LensesExperimental Treatment1 Intervention

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.

Group III: Control Group: Subjects with Normal Color VisionActive Control1 Intervention

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

Group IV: Crossover: Experimental to PlaceboPlacebo Group1 Intervention

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.

Group V: Color Vision Deficient with Placebo LensesPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2022

N/A

~40

Experimental Group 1: Color Correcting Lenses

2022

N/A

~40

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Color blindness treatments primarily aim to enhance color discrimination. One common approach is the use of color-correcting lenses, which alter the wavelengths of light entering the eye. These lenses work by filtering specific wavelengths to enhance the contrast between colors that color-blind individuals typically struggle to differentiate. This mechanism is crucial for color blindness patients as it can significantly improve their ability to perceive colors more accurately, thereby enhancing their daily functioning and quality of life.

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