Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS06 - A Randomized Trial of Near versus Distance Activities while Patching for Amblyopia in Children 3 to < 7 years old
Status: Closed
Start Date: 02/01/2005
End Date: 10/26/2007
Clinical Trial ID: NCT00315198
Public Dataset:  Download


A Randomized Trial of Near versus Distance Activities while Patching for Amblyopia in Children 3 to < 7 years old

Protocol

Objectives:
To determine whether “near” activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with “distance” activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.

Design:
Randomized clinical trial.

Participants:
A total of 425 children, aged 3 to 7 years, with amblyopia (20/40–20/400) that was caused by anisometropia, strabismus, or both, and that persisted after treatment with spectacles.

Methods:
Children were randomized to 2 hours of patching per day with near activities or 2 hours of patching per day with distance activities. Instruction sheets describing common near and distance activities were given to the parents. Study visits were scheduled at 2, 5, 8, and 17 weeks. In weeks without a visit, weekly telephone calls were made to the parent to monitor and encourage compliance during the first 8 weeks.

Main Outcome Measure:
Masked assessment of visual acuity by isolated crowded HOTV optotypes at 8 weeks.

Results:
At 8 weeks, improvement in amblyopic eye visual acuity averaged 2.6 lines in the distance activities group and 2.5 lines in the near activities group (mean difference in acuity between groups, adjusted for baseline acuity, 0.0 lines 95% confidence interval, (-0.3 to 0.3). The 2 groups also appeared statistically similar at the 2-, 5-, and 17-week visits. At the 17-week examination, children with severe amblyopia improved a mean of 3.6 lines with 2 hours of daily patching.

Conclusions:
Performing common near activities does not improve visual acuity outcome when treating anisometropic, strabismic, or combined amblyopia with 2 hours of daily patching. Children with severe amblyopia may respond to 2 hours of daily patching.

Published:

  1. Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology 2008;115:2071-8.

 



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