NCT06049459

Novel Amblyopia Treatment With Virtual Reality Games

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Marjean Kulp · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Optical Correction	Optical correction (if needed)
DEVICE	Therapeutic Dichoptic Virtual Reality Games	Virtual Reality Game play for amblyopia treatment

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-09-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study