Amblyopia, Anisometropia, Strabismus
Conditions
Keywords
Amblyopia, Dichoptic, Virtual reality, Stereopsis, Stereo vision, Visual acuity, Binocular
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.
Interventions
DEVICEDichoptic therapy
Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system
OTHERPatching therapy
Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
DEVICEDioptic (non-dichoptic) therapy
Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in visual acuity | 3 weeks, 6 weeks, and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in stereopsis | 3 weeks, 6 weeks, and 6 months |
| Quality of life | 3 weeks, 6 weeks, and 6 months |
Countries
United States
Outcome results
None listed