NCT02687581

Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

Terminated NA Results posted Last updated 22 November 2022

What this trial tests

NA trial testing IO-therapy Glasses in Amblyopia in 18 participants. Terminated before completion.

Timeline

19 December 2016

Primary endpoint
30 May 2021

30 May 2021

Quick facts

Lead sponsor	Salus University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	18
Start date	19 December 2016
Primary completion	30 May 2021
Estimated completion	30 May 2021
Sites	1 location across United States

Drugs / interventions tested

• IO-therapy Glasses
• patch

Conditions studied

• Amblyopia — all drugs for Amblyopia →

Sponsor

Salus University

Who can join

Adults 3 to 8, any sex, with Amblyopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Acuity Improvement Primary · 12± 1 weeks after treatment

Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.

Group	Value	95% CI
12-hour IO-therapy Glasses	0.05	± 0.07
6-hour Patching	0.17	± 0.23
Deprivation Amblyopia	0.05	± 0.07
Myopic Anisometropic Amblyopia	0.1	± 0.26

Sponsor's own description

This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.

Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.

The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility of monitoring compliance with intermittent occlusion therapy glasses for amblyopia treatment.
   Wang J, Jin J, Malik A, Shoge R, et al · · 2019 · cited 10× · PMID 31271842 · DOI 10.1016/j.jaapos.2019.04.009
2. Occlusion for stimulus deprivation amblyopia.
   Antonio-Santos A, Vedula SS, Hatt SR, Powell C. · · 2020 · cited 8× · PMID 32203629 · DOI 10.1002/14651858.cd005136.pub4