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Dichoptic Virtual Reality Therapy for Amblyopia in Adults

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ClinicalTrials.gov Identifier: NCT02246556
Recruitment Status : Terminated (Recruitment inadequate and investigators leaving the study institution for new positions.)
First Posted : September 22, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Marc Levin, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Amblyopia Anisometropia Strabismus Device: Dichoptic therapy Other: Patching therapy Device: Dioptic (non-dichoptic) therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

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




Primary Outcome Measures :
  1. Change in visual acuity [ Time Frame: 3 weeks, 6 weeks, and 6 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246556


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94117
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Marc Levin, Assistant Professor, Neuro-ophthalmology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02246556     History of Changes
Other Study ID Numbers: 14-14212
093955 ( Other Identifier: UCSF )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Marc Levin, University of California, San Francisco:
Amblyopia
Dichoptic
Virtual reality
Stereopsis
Stereo vision
Visual acuity
Binocular
Additional relevant MeSH terms:
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Amblyopia
Strabismus
Anisometropia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases
Refractive Errors