Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is:

• To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.

• To determine the maximum improvement in vision of the amblyopic eye with each treatment.

• To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

• 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:

• Age 7 to 12 years old (inclusive)

• Amblyopia associated with strabismus, anisometropia, or both

• Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)

• Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)

• Interocular difference >=15 letters (3 lines)

• Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

• Enrolled into the main study

• Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)

• Birth weight >1500 grams

• No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria:

• Amblyopia treatment (other than spectacles) in the last 6 months

• Myopia (more than -0.25D spherical equivalent) in either eye