Dichoptic Virtual Reality Therapy for Amblyopia in Adults

May 1, 2017 updated by: Marc Levin, University of California, San Francisco
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94117
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in visual acuity
Time Frame: 3 weeks, 6 weeks, and 6 months
3 weeks, 6 weeks, and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-14212
  • 093955 (Other Identifier: UCSF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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