Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency
Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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)
Locations
United States
Texas
University of the Incarnate Word Rosenberg School of Optometry
San Antonio
Time Frame
Start Date: 2022-07-28
Completion Date: 2024-03-31
Participants
Target number of participants: 35
Treatments
Experimental: Color Vision Deficient with Color Correcting Lenses
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.
Placebo_comparator: Color Vision Deficient with Placebo Lenses
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.
Experimental: Crossover: Placebo to Experimental
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.
Placebo_comparator: Crossover: Experimental to Placebo
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.
Active_comparator: Control Group: Subjects with Normal Color Vision
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
Related Therapeutic Areas
Sponsors
Leads: University of the Incarnate Word
Collaborators: National Eye Institute (NEI)