Dichoptic Virtual Reality Therapy for Amblyopia in Adults

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 1

Conditions: Strabismus; Amblyopia; Anisometropia

Treatments: Other: Patching therapy; Device: Dioptic (non-dichoptic) therapy; Device: Dichoptic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02246556

093955 (Other Identifier)

14-14212

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups

Patching therapy

Active Comparator group

Description:

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.

Treatment:

Other: Patching therapy

Dioptic (non-dichoptic) therapy

Active Comparator group

Description:

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.

Treatment:

Device: Dioptic (non-dichoptic) therapy

Dichoptic therapy

Experimental group

Description:

Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system.

Treatment:

Device: Dichoptic therapy