Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial.

Purpose: To investigate efficacy of over-glasses patching treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.

Methods: In a randomized multi-center controlled clinical trial, 107 children aged 3-7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) were included to receive treatment with either an adhesive skin patch or a fabric over-glasses patch. The patients were prescribed 2 h of patching per day for the sound eye. Best-corrected visual acuity (BCVA) was investigated and ATI questionnaires were collected from parents at 5 weeks and 17 weeks after the initiation of treatment. ATI identifies barriers and problems associated with amblyopia treatment. We compared the changes of visual acuity of amblyopic eyes and ATI scores in two groups.

Results: At 17 weeks, the mean visual acuity of the amblyopic eye using Snellen chart improved 3.2 lines in the adhesive patching group and 2.7 lines for an over-glasses patching method that fit over eyeglasses (p = 0.345). A similar proportion of subjects in each group had improvement of ≥ 2 lines (adhesive patching group 67% vs over-glasses patching group 67%, p = 0.372). There was also no difference in treatment burden in each group as measured with the Amblyopia Treatment Index. The only item to demonstrate a significant difference between groups was that related to "Treatment makes the eye or eyelids red" (mean 4.0 ± 1.1 vs 3.0 ± 1.0 at 17 weeks, p = 0.001, for adhesive vs over-glasses patch).

Conclusions: Over-glasses patching treatment is a useful option for amblyopia treatment when the patients suffer from adverse effects of using adhesive skin patching.