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Dichoptic Virtual Reality Therapy for Amblyopia in Adults

Primary Purpose

Amblyopia, Anisometropia, Strabismus

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dichoptic therapy
Patching therapy
Dioptic (non-dichoptic) therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopia, Dichoptic, Virtual reality, Stereopsis, Stereo vision, Visual acuity, Binocular

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept 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).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Patching therapy

Dioptic (non-dichoptic) therapy

Dichoptic therapy

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change in visual acuity

Secondary Outcome Measures

Change in stereopsis
Quality of life

Full Information

First Posted
September 17, 2014
Last Updated
May 1, 2017
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02246556
Brief Title
Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Official Title
Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment inadequate and investigators leaving the study institution for new positions.
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Anisometropia, Strabismus
Keywords
Amblyopia, Dichoptic, Virtual reality, Stereopsis, Stereo vision, Visual acuity, Binocular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patching therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Dioptic (non-dichoptic) therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Dichoptic therapy
Arm Type
Experimental
Arm Description
Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system.
Intervention Type
Device
Intervention Name(s)
Dichoptic therapy
Intervention Description
Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system
Intervention Type
Other
Intervention Name(s)
Patching therapy
Intervention Description
Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
Intervention Type
Device
Intervention Name(s)
Dioptic (non-dichoptic) therapy
Intervention Description
Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
Primary Outcome Measure Information:
Title
Change in visual acuity
Time Frame
3 weeks, 6 weeks, and 6 months
Secondary Outcome Measure Information:
Title
Change in stereopsis
Time Frame
3 weeks, 6 weeks, and 6 months
Title
Quality of life
Time Frame
3 weeks, 6 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States

12. IPD Sharing Statement

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Dichoptic Virtual Reality Therapy for Amblyopia in Adults

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