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TerminatedNCT02246556Updated May 3, 2017

Dichoptic Virtual Reality Therapy for Amblyopia in Adults

A Phase 1 interventional study of Dichoptic therapy and Patching therapy in Amblyopia, Anisometropia and Strabismus, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment

Why this study was terminated
Recruitment inadequate and investigators leaving the study institution for new positions.
Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
15 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Amblyopia
  • Anisometropia
  • Strabismus

Keywords

  • Amblyopia
  • Dichoptic
  • Virtual reality
  • Stereopsis
  • Stereo vision
  • Visual acuity
  • Binocular
03

In context

Amblyopia

183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.

This study's enrollment of 17 is below the median of 60 across 133 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
17 participants (actual)

Study arms

  • 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

  • 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

  • Experimental
    Dichoptic therapy

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

    Device: Dichoptic therapy

Interventions

  • DeviceDichoptic therapy

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

  • OtherPatching therapy

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

  • DeviceDioptic (non-dichoptic) therapy

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

06

What researchers measure

Primary outcomes

  1. Change in visual acuity

    Time frame: 3 weeks, 6 weeks, and 6 months

Secondary outcomes

  1. Change in stereopsis

    Time frame: 3 weeks, 6 weeks, and 6 months

  2. Quality of life

    Time frame: 3 weeks, 6 weeks, and 6 months

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94117, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02246556
Lead sponsor
University of California, San Francisco
Responsible party
Marc Levin (Assistant Professor, Neuro-ophthalmology, University of California, San Francisco) — Principal investigator
First posted
Sep 22, 2014
Start date
Oct 2014
Primary completion
Apr 2016
Completion
Apr 2016
Last update
May 3, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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