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Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

NCT00944710 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-03-06

Study results available
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Summary

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but 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 weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Conditions

  • Amblyopia

Interventions

DRUG

Atropine

Weekend atropine 1%

DEVICE

Plano lens

plano lens over the sound eye

DRUG

Atropine

Weekend atropine 1%

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
2013-10-31
Completion
2013-11-30

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 NCT00944710 on ClinicalTrials.gov