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Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

NCT02687581 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-11-22

Study results available
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Summary

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.

Conditions

  • Amblyopia

Interventions

DEVICE

IO-therapy Glasses

12-hour of 50% intermittent occlusion therapy on the fellow eye.

DEVICE

patch

6-hour of eye patch on the fellow eye

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Salus University

    lead OTHER

Principal Investigators

  • Jingyun Wang, PhD · Salus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687581 on ClinicalTrials.gov