Salus Univerisity Pennsylvania College of Optometry, 8360 Old York Rd, Elkins Park, PA, 19027, USA.
Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Trials. 2020 Apr 28;21(1):361. doi: 10.1186/s13063-020-04284-4.
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.
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.
ClinicalTrials.gov: NCT02767856. Registered on 10 May 2016.
我们曾在之前的研究中报告，间歇性遮盖治疗（IO-therapy）4 小时与遮盖 2 小时对 3 至 8 岁弱视儿童的疗效相当。我们假设每天 12 小时的强化 IO-therapy 方案（连续佩戴 4 周）与每天 4 小时的标准 IO-therapy 方案（连续佩戴 12 周）在治疗 3 至 8 岁儿童的中度弱视方面可能同样有效。
方法/设计：共招募 56 名 3 至 8 岁伴有屈光不正和/或斜视的弱视儿童。所有参与者都将被处方 IO-therapy 眼镜（Amblyz™），设定为 30 秒的不透明/透明间隔（即，佩戴时间的 50%被遮盖）。他们将被随机分配接受标准方案 12 周或强化方案 4 周。通过微传感器剂量监测器客观监测每位参与者对 IO-therapy 眼镜的使用依从性。主要研究目的是比较强化方案与标准方案在治疗 3 至 8 岁中度弱视儿童中的有效性。次要研究目的是确定强化方案和标准方案的 IO-therapy 之间的依从性是否存在差异，以及确定 IO-therapy 的剂量反应关系。
除了测试疗效外，本研究还将首次测试 IO-therapy 治疗依从性与视觉结果之间的关系，这将增进我们对 IO-therapy 剂量反应关系的理解。如果强化方案被证明有效，它将改变弱视治疗策略并提高视觉结果。
ClinicalTrials.gov：NCT02767856。注册于 2016 年 5 月 10 日。
