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Regimens of Intermittent Occlusion Therapy for Amblyopia in Children

NCT02767856 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-07-25

Study results available
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Summary

This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?

Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.

Conditions

  • Amblyopia

Interventions

DEVICE

IO-therapy Glasses

Sponsors & Collaborators

  • Salus University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
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 NCT02767856 on ClinicalTrials.gov