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

Completed · Phase 3

Conditions studied: Amblyopia

In brief

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.

Key facts

Study ID

NCT00315328

Run by

Jaeb Center for Health Research

People needed

233

Starts

2005-08-01

Expected to finish

2008-01-01

Last updated by the study team

2016-06-24

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Amblyopia treatment (other than spectacles) in the last 6 months
• Myopia (more than -0.25D spherical equivalent) in either eye

Where it is running

• Pennsylvania College of Optometry — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.