Amblyopia Treatment Study
Atropine
+ Patch
Brain Diseases+12
+ Central Nervous System Diseases
+ Cranial Nerve Diseases
Treatment Study
Summary
Study start date: May 1, 1999
Actual date on which the first participant was enrolled.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 provide more precise estimates of treatment kinetics than now available.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location