Assessment of Device for Treatment of Amblyopia

Visior Technologies

Status: Completed

Conditions: Amblyopia

Treatments: Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min

Study type: Interventional

Funder types: Industry

Identifiers

NCT02003235

RV-TMSC-1

Details and patient eligibility

About

The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.

The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.

Enrollment: 35 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Refractive or Strabismic Amblyopia, with best corrected visual acuity.

(1) Refractive Amblyopia, visual acuity score <6:15 (worse then)

• or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30

Exclusion criteria

Diagnosed with epilepsy, recently treated with occlusion or penalization therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Single Arm

Experimental group

Description:

Daily watching videos using Reviview™, a dichoptic video display device

Treatment:

Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min