Trials (Apr 2020)

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

DOI
https://doi.org/10.1186/s13063-020-04284-4
Journal volume & issue
Vol. 21, no. 1
pp. 1 – 8

Abstract

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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.

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