NCT02246556

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

September 17, 2014

Last Update Submit

May 1, 2017

Conditions

AmblyopiaAnisometropiaStrabismus

Keywords

AmblyopiaDichopticVirtual realityStereopsisStereo visionVisual acuityBinocular

Outcome Measures

Primary Outcomes (1)

  • Change in visual acuity

    3 weeks, 6 weeks, and 6 months

Secondary Outcomes (2)

  • Change in stereopsis

    3 weeks, 6 weeks, and 6 months

  • Quality of life

    3 weeks, 6 weeks, and 6 months

Study Arms (3)

Patching therapy

ACTIVE COMPARATOR

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

Dioptic (non-dichoptic) therapy

ACTIVE COMPARATOR

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

Dichoptic therapy

EXPERIMENTAL

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

Device: Dichoptic therapy

Interventions

Dichoptic therapyDEVICE

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

Dichoptic therapy
Patching therapyOTHER

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

Patching therapy
Dioptic (non-dichoptic) therapyDEVICE

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

Dioptic (non-dichoptic) therapy

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94117, United States

Location

MeSH Terms

Conditions

AmblyopiaAnisometropiaStrabismus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive ErrorsOcular Motility DisordersCranial Nerve Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Neuro-ophthalmology

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 22, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)