Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ Patients ages 5 to 17 years of age

• Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd

• Age normal VA in the nonamblyopic eye

• Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)

• Interocular difference of ≥ 3 lines

• No amblyopia treatment in the past 2 weeks

• An interpupillary distance of 52-72 mm (inclusive)

Locations
United States
Ohio
The Ohio State University College of Optometry
RECRUITING
Columbus
Contact Information
Primary
Marjean T Kulp, OD, MS
kulp.6@osu.edu
614-688-3336
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 8
Treatments
Active_comparator: Optical Correction alone
Optical correction alone (16 weeks) (Each participant will complete both study conditions.)
Experimental: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)
Related Therapeutic Areas
Sponsors
Leads: Marjean Kulp
Collaborators: Beta Sigma Kappa - College of Optometrists in Vision Development, VividVision

This content was sourced from clinicaltrials.gov