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


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.

SUBMITTER: Wang J 

PROVIDER: S-EPMC7189599 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Wang Jingyun J   Malik Ayesha A   Jin Jing J   Pang Yi Y   Yin Kelly K   Allen Megan M   Grigorian Adriana A   Scombordi Brandy B   Bailey Joann J   Aljohani Saeed S   Funari Katharine K   Shoge Ruth R   Meiyeppen Siva S   Myung Jenny J   Soni Ajay A   Neely Daniel E DE  

Trials 20200428 1


<h4>Background</h4>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.<h4>Methods/design</h4>A total of 56 children between 3 an  ...[more]

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