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Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old

NCT00315302 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-07-19

Study results available
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Summary

The purpose of the study is:

* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Conditions

  • Amblyopia

Interventions

DRUG

Atropine

Atropine 1% once each weekend day

DEVICE

Plano Lens

Plano lens for the sound eye

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • David Weakley, M.D. · UT Southwestern Medical Center

  • Susan A. Cotter, O.D. · Southern California College of Optometry at Marshall B. Ketchum University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-10-31
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 NCT00315302 on ClinicalTrials.gov