Dichoptic Virtual Reality Therapy for Amblyopia in Adults

Amblyopia Clinical Trial

Official title:

Dichoptic Virtual Reality Therapy for Amblyopia in Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02246556
• Other study ID #: 14-14212
• Secondary ID: 093955
• Status: Terminated
• Phase: Phase 1
• First received: September 17, 2014
• Last updated: May 1, 2017
• Start date: October 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Amblyopia
• Anisometropia
• Strabismus

Intervention

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

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

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity		3 weeks, 6 weeks, and 6 months
Secondary	Change in stereopsis		3 weeks, 6 weeks, and 6 months
Secondary	Quality of life		3 weeks, 6 weeks, and 6 months