Increasing Patching for Amblyopia in Children 3 to < 8 Years Old

Completed · Phase 3

Conditions studied: Amblyopia

In brief

This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Key facts

Study ID

NCT00945100

Run by

Jaeb Center for Health Research

People needed

169

Starts

2009-08-01

Expected to finish

2013-03-01

Last updated by the study team

2016-07-13

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Major Eligibility Criteria for Run-in Phase
• Age 3 to < 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
• Amblyopia treatment within the past 6 months subject to the following stipulations:
• No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
• No simultaneous treatment with patching and atropine
• No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
• Maximum level of treatment within the past 6 months:
• Patching: up to 2 hours daily
• Atropine: up to once daily
• Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.
• Eligibility Criteria for Randomization:
• Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
• Reasonable compliance with prescribed treatment, defined as wearing the patch at least 10 hours per week.

You may not qualify if…

• Currently using vision therapy or orthoptics
• Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
• Prior intraocular or refractive surgery
• Known skin reaction to patch or bandage adhesives

Where it is running

• Southern California College of Optometry — Fullerton, California, United States
• Duke University Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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