Dichoptic Virtual Reality Therapy for Amblyopia in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Dichoptic Virtual Reality Therapy for Amblyopia in Adults

Conditions
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Amblyopia, Anisometropia, Strabismus

Intervention / Treatment
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* Device: Dichoptic therapy
* Other: Patching therapy
* Device: Dioptic (non-dichoptic) therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patching therapy<br>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. | Other: Patching therapy<br>* Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software<br>|
| Active Comparator: Dioptic (non-dichoptic) therapy<br>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. | Device: Dioptic (non-dichoptic) therapy<br>* Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software<br>|
| Experimental: Dichoptic therapy<br>Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system. | Device: Dichoptic therapy<br>* Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity |  | 3 weeks, 6 weeks, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stereopsis |  | 3 weeks, 6 weeks, and 6 months | 
| Quality of life |  | 3 weeks, 6 weeks, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amblyopia, Dichoptic, Virtual reality, Stereopsis, Stereo vision, Visual acuity, Binocular