Wang, JingyunMalik, AyeshaJin, JingPang, YiYin, KellyAllen, MeganGrigorian, AdrianaScombordi, BrandyBailey, JoannAljohani, SaeedFunari, KatharineShoge, RuthMeiyeppen, SivaMyung, JennySoni, AjayNeely, Daniel E.2020-07-302020-07-302020-04-28Wang, J., Malik, A., Jin, J., Pang, Y., Yin, K., Allen, M., Grigorian, A., Scombordi, B., Bailey, J., Aljohani, S., Funari, K., Shoge, R., Meiyeppen, S., Myung, J., Soni, A., & Neely, D. E. (2020). Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial. Trials, 21(1), 361. https://doi.org/10.1186/s13063-020-04284-4https://hdl.handle.net/1805/23455Background: 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.en-USAttribution 4.0 InternationalAmblyopiaChildIntermittent occlusion therapyIntense regimenRandomized clinical triaVisual acuityArticle