Search / Trial NCT00001864

Amblyopia (Lazy Eye) Treatment Study

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

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Lazy Eye Atropine Penalization Patching Vision Loss Amblyopia

Description

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 Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0