Dichoptic Virtual Reality Therapy for Amblyopia in Adults

Phase 1

Terminated

• Conditions: Amblyopia; Strabismus; Anisometropia
• Interventions: Other: Patching therapy; Device: Dichoptic therapy; Device: Dioptic (non-dichoptic) therapy

• Registration Number: NCT02246556
• Lead Sponsor: University of California, San Francisco

Brief Summary

This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Study Start: 2014-10
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Interpupillary distance of 60-66 mm
• Age 15-40
• Anisometropic amblyopia or strabismic amblyopia
• Best corrected visual acuity of 20/30 or worse in the amblyopic eye
• No prior therapeutic use of the software
• No other ongoing therapies including patching or recent eye muscle surgery
• No vested interest in the product
• Ability attend visits and complete the training session, and to stop the intervention after the specified intervention period

Exclusion Criteria

• Stimulus-deprivation amblyopia.
• Organic lesions of the eye preventing the establishment of good vision (eg. media opacities, abnormalities in the fundus or optic nerve).
• Lesions of the brain preventing the establishment of good vision (eg. cortical visual impairment).
• Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
• Patients diagnosed with Photosensitive Epilepsy.
• Inability to comply with the follow-up visits required.
• History of pathologic nystagmus (congenital or sensory).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patching therapy	Patching therapy	Patching treatment followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.
Dichoptic therapy	Dichoptic therapy	Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system.
Dioptic (non-dichoptic) therapy	Dioptic (non-dichoptic) therapy	Dioptic (non-dichoptic) therapy followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.

Primary Outcome Measures

Name	Time	Method
Change in visual acuity	3 weeks, 6 weeks, and 6 months

Secondary Outcome Measures

Name	Time	Method
Change in stereopsis	3 weeks, 6 weeks, and 6 months
Quality of life	3 weeks, 6 weeks, and 6 months

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States