Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

NCT00315198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2010-03-24

No results posted yet for this study

Summary

Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.

Conditions

  • Amblyopia

Interventions

DEVICE

Eye Patch

2 hours daily patching

PROCEDURE

Near activities

near visual activities while patching

PROCEDURE

Distance activities

distance visual activities while patching

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH
  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Don Lyon, O.D. · Indiana University

  • Jonathan M. Holmes, M.D. · Mayo Clinic Department of Ophthalmology

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
2007-12-31
Completion
2007-12-31

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 NCT00315198 on ClinicalTrials.gov