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Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children

NCT00091923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2010-03-24

No results posted yet for this study

Summary

The objectives of the Spectacle Phase are:

* In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine

1. the incidence of resolution of amblyopia with spectacle correction alone and
2. the time course of visual acuity improvement with spectacle correction alone.
* In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.

The objectives of the Randomized Trial are:

* To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
* To determine the maximal improvement and time course of improvement with this patching treatment regimen.

Conditions

  • Amblyopia

Interventions

DEVICE

Eye patch

DEVICE

Spectacles

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • David K. Wallace, M.D. · Duke University Eye 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
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Completion
2005-12-31

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 NCT00091923 on ClinicalTrials.gov