Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia

Stopped early · Phase 3

Conditions studied: Amblyopia

In brief

This study is comparing the effectiveness of patching combined with active vision therapy plus near activities versus patching combined with control vision therapy plus near activities for moderate amblyopia (20/40-20/100) in 7 to \<13 year olds. The primary outcome measure is the proportion of patients with visual acuity of 20/25 or better in the amblyopic eye at the 17-week masked exam. These patients will be considered treatment responders. The primary analysis will consist of a comparison between the 2 treatment groups of the proportion of treatment responders with adjustment for baseline visual acuity. Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual acuity at the 17-week masked exam, and rate of improvement of visual acuity.

Key facts

Study ID

NCT00587171

Run by

Jaeb Center for Health Research

People needed

19

Starts

2008-04-01

Expected to finish

2009-10-01

Last updated by the study team

2016-07-13

Who can join

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

You may qualify if…

• Age 7 to <13 years
• Amblyopia associated with anisometropia, strabismus (comitant or incomitant), or both at the time of the eligibility examination
• Visual acuity in the amblyopic eye between 49 and 71 letters inclusive (20/40 to 20/100 inclusive) on the eETDRS
• Visual acuity in the sound eye of 79 or more letters on the eETDRS (20/25 or better)
• Inter-eye acuity difference of 15 or more letters (3 or more logMAR lines)
• At least 800 seconds of arc on the Randot Preschool Stereoacuity Test
• Previous or current amblyopia treatment with spectacles or contact lenses, patching or atropine is permitted.
• No myopia more than -6.00 D spherical equivalent in the amblyopic eye
• Single vision spectacles, if needed, worn for at least 16 weeks or until visual acuity documented to be stable
• The child has access to a computer on a daily basis (to use the home vision therapy software)

You may not qualify if…

• Previous vision therapy or orthoptics
• Known skin reactions to patch or bandage adhesives
• Prior intraocular or refractive surgery
• Bifocals
• Constant strabismus at near at the eligibility examination
• A family member is (or has been) enrolled in this study

Where it is running

• UAB Pediatric Eye Care; Birmingham Health Care — Birmingham, Alabama, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Indiana University School of Optometry — Bloomington, Indiana, United States
• Casey Eye Institute — Portland, Oregon, United States
• Pediatric Ophthalmology of Erie — Erie, Pennsylvania, United States
• Family Eye Group — Lancaster, Pennsylvania, United States
• Southern College of Optometry — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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