Combined Patching-Atropine for Residual Amblyopia

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.

The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.

• 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 3 to < 10 years

• Amblyopia associated with strabismus, anisometropia, or both

• Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive

• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2 logMAR lines

• Current/previous treatment with patching and/or atropine subject to the following stipulations:

• No simultaneous treatment with patching and atropine in the past 6 months

• No prior use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D

• Maximum level of any previous treatment:

• Patching: up to 42 hours per week (averaging 6 hours daily)

• Atropine: up to once daily

• Current treatment with 42 hours per week patching or daily atropine

• No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 6 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement defined as follows:

• No lines of improvement

• For patients tested using E-ETDRS, letter score that is no more than 4 letters improved

• Wearing spectacles with optimal correction (if applicable)

• Investigator ready to wean or stop treatment

Exclusion Criteria:

• Current vision therapy or orthoptics

• Ocular cause for reduced visual acuity

• Prior intraocular or refractive surgery

• Strabismus surgery planned within 10 weeks

• Known allergy to atropine or other cycloplegic drugs

• Known skin reactions to patch or bandage adhesives

• Down Syndrome present