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Increasing Patching for Amblyopia in Children 3 to < 8 Years Old

NCT00945100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2016-07-13

Study results available
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Summary

This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Conditions

  • Amblyopia

Interventions

DEVICE

Eye Patch

42 hours patching per week (averaging 6 hours patching daily)

DEVICE

Eye Patch

2 hours patching daily

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

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
2009-08-31
Primary Completion
2013-03-31
Completion
2013-03-31

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 NCT00945100 on ClinicalTrials.gov