Trials
Search / Trial NCT00001864

Amblyopia (Lazy Eye) Treatment Study

Launched by NATIONAL EYE INSTITUTE (NEI) · May 21, 2002

Trial Information

Current as of January 15, 2025

Completed

Keywords

Lazy Eye Atropine Penalization Patching Vision Loss Amblyopia

ClinConnect Summary

The Amblyopia Treatment Study (ATS) has been designed as a randomized, controlled single-masked multi-center clinical trial with the following objectives:

To determine whether the success rate with atropine treatment of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy.

To develop more precise estimates of the success rates of amblyopia treatment.

To identify factors that may be associated with successful treatment of amblyopia.

To collect data on the clinical course of treated amblyopia to ...

Gender

ALL

Eligibility criteria

  • Age less than 7 years.
  • Able to measure surrounded single optotype visual acuity using the ATS BVAT protocol.
  • Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both.
  • No more than 2 months of amblyopia therapy in the past 2 years.
  • No current vision therapy or orthoptics.
  • Visual acuity in the sound eye greater than or equal to 20/40.
  • Visual acuity in the amblyopic eye less than or equal to 20/40 and greater than or equal to 20/100.
  • Inter-eye acuity difference (IAD) greater than or equal to 3 LogMAR lines.
  • No ocular cause for reduced visual acuity.
  • Cycloplegic refraction and ocular examination within 2 months of enrollment.
  • No myopia.
  • Hyperopic/astigmatic refractive error, if present, corrected for at least 4 weeks.
  • No prior intraocular surgery.
  • Downs Syndrome not present.
  • No known skin reactions to patch or bandage adhesives.
  • No known allergy to atropine or other cycloplegics.
  • Availability for at least 6 months of follow-up, has a home phone (or access to phone), and willing to be contacted by Jaeb Center staff.

About National Eye Institute (Nei)

The National Eye Institute (NEI), part of the U.S. National Institutes of Health (NIH), is dedicated to conducting and supporting innovative research to understand, prevent, and treat eye diseases and vision disorders. As a leading sponsor of clinical trials, NEI aims to advance knowledge in ocular health through rigorous scientific inquiry and collaboration with researchers, healthcare professionals, and institutions. By fostering the development of new therapies and technologies, NEI plays a pivotal role in enhancing the quality of life for individuals affected by visual impairments and eye conditions.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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