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A randomized pilot study of near activities versus non-near activities during patching therapy for amblyopia
Jonathan M Holmes1, Allison R Edwards, Roy W Beck
1Jaeb Center for Health Research, 15310 Amberly Drive, Tampa, FL 33647, USA. pedig@jaeb.org
Insights
Children with amblyopia (lazy eye) who performed near activities while patching showed potential visual acuity improvement. This pilot study suggests near activities may benefit amblyopia treatment, warranting further research.
Area of Science:
- Ophthalmology
- Pediatric Medicine
- Clinical Research
Background:
- Pilot study to inform a future randomized clinical trial on amblyopia treatment.
- Investigated adherence to prescribed near vs. non-near activities during patching.
- Assessed preliminary effects of near activities on visual acuity in amblyopia.
Purpose of the Study:
- To determine if children adhere to prescribed near or non-near activities during patching for amblyopia.
- To estimate the effect of near activities combined with patching on amblyopic eye visual acuity.
Main Methods:
- Sixty-four children (3-7 years) with amblyopia were randomized to 2 hours daily patching with or without near activities.
- Parents recorded activities via daily calendars and weekly phone calls over 4 weeks.
- Visual acuity was measured at the study's conclusion.
Main Results:
- Children assigned near activities performed significantly more near tasks (1.6 hours/day) than the non-near group (0.2-0.4 hours/day).
- A trend towards greater visual acuity improvement was observed in the near activity group (2.6 lines vs. 1.6 lines).
- This visual acuity benefit was more pronounced in severe amblyopia cases.
Conclusions:
- Children adhere better to near activities when instructed during patching for amblyopia.
- Performing near activities while patching shows promise for improving amblyopia visual acuity.
- The study supports the feasibility and desirability of a larger randomized trial for patching with near activities.
Background:
To plan a future randomized clinical trial, we conducted a pilot study to determine whether children randomized to near or non-near activities would perform prescribed activities. A secondary aim was to obtain a preliminary estimate of the effect of near versus non-near activities on amblyopic eye visual acuity, when combined with 2 hours of daily patching.
Methods:
Sixty-four children, 3 to less than 7 years of age, with anisometropic, strabismic, or combined amblyopia (20/40 to 20/400) were randomly assigned to receive either 2 hours of daily patching with near activities or 2 hours of daily patching without near activities. Parents completed daily calendars for 4 weeks recording the activities performed while patched and received a weekly telephone call in which they were asked to describe the activities performed during the previous 2 hours of patching. Visual acuity was assessed at 4 weeks.
Results:
The children assigned to near visual activities performed more near activities than those assigned to non-near activities (by calendars, mean 1.6 +/- 0.5 hours versus 0.2 +/- 0.2 hours daily, P < 0.001; by telephone interviews, 1.6 +/- 0.4 hours versus 0.4 +/- 0.5 hours daily, P < 0.001). After 4 weeks of treatment, there was a suggestion of greater improvement in amblyopic eye visual acuity in those assigned to near visual activities (mean 2.6 lines versus 1.6 lines, P = 0.07). The treatment group difference in visual acuity was present for patients with severe amblyopia but not moderate amblyopia.
Conclusions:
Children patched and instructed to perform near activities for amblyopia spent more time performing those near activities than children who were instructed to perform non-near activities. Our results suggest that performing near activities while patched may be beneficial in treating amblyopia. Based on our data, a formal randomized amblyopia treatment trial of patching with and without near activities is both feasible and desirable.