Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

• To determine whether the success rate with drug treatment (atropine) 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 course of treated amblyopia to provide more precise estimates of treatment effects than are now available

Extended Follow up of Study Patients

• Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.

• Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborator: National Eye Institute (NEI)
• Treatments: Atropine

Criteria

Inclusion Criteria:

• Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia

• Visual acuity in the amblyopic eye must be between 20/40 and 20/100

• Visual acuity in the sound eye or 20/40 or better

• At least 3 lines of acuity difference between the two eyes

Exclusion Criteria:

• More than two months of amblyopia therapy in the past two years

• Myopia (more than -0.50 D)