Novel Amblyopia Treatment With Virtual Reality Games

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Marjean Kulp
Study ID
NCT06049459
Status
Recruiting
Apply to this trial

Conditions

  • Amblyopia

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Optical Correction — DEVICE
    Optical correction (if needed)
  • Therapeutic Dichoptic Virtual Reality Games — DEVICE
    Virtual Reality Game play for amblyopia treatment

Study Details

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

Key Dates

Start date
Mar 14, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.)

Primary Outcome Measure

Difference in Mean Change in Amblyopic Eye Visual Acuity [ Time Frame: Baseline to 16 weeks versus 16 weeks to 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University College of OptometryColumbusOhio43210
Marjean T Kulp, OD, MS
[email protected]
614-688-3336

Find similar trials in Columbus, OH

By research site
The Ohio State University College of Optometry· Columbus, OH

Related Studies