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Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

NCT00315328 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2016-06-24

Study results available
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Summary

The purpose of this study is:

* To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds.
* To determine the maximum improvement in vision of the amblyopic eye with each treatment.
* To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Conditions

  • Amblyopia

Interventions

DRUG

Atropine

Atropine 1% each weekend day in the sound eye

DEVICE

Patching

Patching 2 hours per day

PROCEDURE

Near activities

near visual activities for at least one hour per day

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Richard W. Hertle, M.D. · University of Pittsburgh

  • Mitchell M. Scheiman, O.D. · Pennsylvania College of Optometry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-12-31
Completion
2008-01-31

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 NCT00315328 on ClinicalTrials.gov