Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial

Jingyun Wang, Ayesha Malik, Jing Jin, Yi Pang, Kelly Yin, Megan Allen, Adriana Grigorian, Brandy Scombordi, Joann Bailey, Saeed Aljohani, Katharine Funari, Ruth Shoge, Siva Meiyeppen, Jenny Myung, Ajay Soni, Daniel E Neely, Jingyun Wang, Ayesha Malik, Jing Jin, Yi Pang, Kelly Yin, Megan Allen, Adriana Grigorian, Brandy Scombordi, Joann Bailey, Saeed Aljohani, Katharine Funari, Ruth Shoge, Siva Meiyeppen, Jenny Myung, Ajay Soni, Daniel E Neely

Abstract

Background: We reported that in our previous study that wearing intermittent occlusion therapy glasses (IO-therapy) for 4 hours (h) was non-inferior to patching for 2 h in 3 to 8-year-old children with amblyopia. We hypothesize that an intense regimen of 12-h IO-therapy per day for 4 weeks could be as effective as the standard regimen of 4-h IO-therapy per day for 12 weeks in treating moderate amblyopia in 3 to 8-year-old children.

Methods/design: A total of 56 children between 3 and 8 years of age with amblyopia in association with anisometropia and/or strabismus will be enrolled. All participants will be prescribed IO-therapy glasses (Amblyz™), set at 30-s opaque/transparent intervals (i.e., occluded 50% of wear time). They will be randomized to receive the standard regimen for 12 weeks or the intense regimen for 4 weeks. Adherence to using the IO-therapy glasses will be objectively monitored in each participant by means of a microsensor dose monitor. The primary study objective is to compare the effectiveness of an intense regimen to a standard regimen of IO-therapy in 3 to 8-year-old children with moderate amblyopia. The secondary study objectives are to determine whether adherence differs between an intense regimen and a standard regimen of IO-therapy, and to determine the dose-response relationship of IO-therapy.

Discussion: In addition to testing the effectiveness, this study will test for the first time the association between treatment adherence and the visual outcome of IO-therapy, which will enhance our understanding of the dose-response relationship of IO-therapy. If an intense regimen is shown to be effective, it would alter amblyopia treatment strategies and improve visual outcomes.

Trial registration: ClinicalTrials.gov: NCT02767856. Registered on 10 May 2016.

Keywords: Amblyopia; Child; Intense regimen; Intermittent occlusion therapy; Randomized clinical trial; Visual acuity.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study participant flow. IO-therapy, intermittent occlusion therapy
Fig. 2
Fig. 2
Standard protocol items: recommendation for interventional trials (SPIRIT) figure. IO-therapy, intermittent occlusion therapy

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