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Combined Patching-Atropine for Residual Amblyopia

NCT00506675 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-07-13

Study results available
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Summary

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to \< 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.

The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.

Conditions

  • Amblyopia

Interventions

DEVICE

Patching

42 hours per week of patching

DRUG

Atropine

daily atropine (1%)

DEVICE

Patching

two hours of daily patching for 4 weeks, then no treatment

DRUG

Atropine

once weekly atropine for 4 weeks, then no treatment

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
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-04-30
Completion
2009-09-30

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 NCT00506675 on ClinicalTrials.gov