Dichoptic Virtual Reality Therapy for Amblyopia in Adults

NCT ID: NCT02246556

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-04-30

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.

Detailed Description

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Conditions

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Amblyopia Anisometropia Strabismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Patching therapy

Intervention Type OTHER

Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software

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.

Group Type ACTIVE_COMPARATOR

Dioptic (non-dichoptic) therapy

Intervention Type DEVICE

Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software

Dichoptic therapy

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

Group Type EXPERIMENTAL

Dichoptic therapy

Intervention Type DEVICE

Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system

Interventions

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Dichoptic therapy

Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system

Intervention Type DEVICE

Patching therapy

Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software

Intervention Type OTHER

Dioptic (non-dichoptic) therapy

Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software

Intervention Type DEVICE

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).
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Marc Levin

Assistant Professor, Neuro-ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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093955

Identifier Type: OTHER

Identifier Source: secondary_id

14-14212

Identifier Type: -

Identifier Source: org_study_id

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