Abstract
BackgroundWe 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/DesignA 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.DiscussionIn 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 registrationClinicalTrials.gov: NCT02767856. Registered on 10 May 2016.
Highlights
We reported that in our previous study that wearing intermittent occlusion therapy glasses (IOtherapy) for 4 hours (h) was non-inferior to patching for 2 h in 3 to 8-year-old children with amblyopia
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 doseresponse relationship of IO-therapy
Adverse events We monitor for potential major adverse events to include reverse amblyopia in the non-amblyopic eye, significant changes in ocular alignment, or any injury associated with the IO-therapy glasses or the microsensor
Summary
The trial protocol described aims to compare two regimens of IO-therapy glasses when treating children ages 3 to < 8 years who have unilateral amblyopia. We will have participants in the intense group return at 4 weeks and stop the treatment for 8 weeks, return for assessment of the primary outcome. Because this is a pilot study on the regimen, our IRB has concerns about the ethical issue of stopping treatment and requests us to continue to treat participants if they show improvement with IO-therapy. In this phase, we are not able to test this hypothesis.
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