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Abstract：
BACKGROUND: Myopia is increasing in prevalence worldwide. Combination therapy showed a better effect on myopia control than monotherapy. Repeated low-level red light therapy (RLRL) therapy and defocus-incorporated multiple segment (DIMS) spectacle lenses have been reported to retard myopia progression significantly. However, whether these two therapies are better than one is still unknown. The present study aims to report the study protocol of a trial designed to evaluate the efficacy and safety of combination therapy of RLRL and DIMS versus DIMS alone for reducing the progression of myopia among Chinese school-aged children.
METHODS: This study is a 12-month, randomized, parallel-controlled, single-center clinical trial. We will recruit children aged 8-12 years with spherical equivalence (SE) between - 0.50 D and - 6.00 D under cycloplegia in both eyes. We will recruit 66 participants with an allocation ratio of 1:1 from our hospital. Participants in the intervention group will be treated with an RLRL therapy device twice a day from Monday to Friday at home, 3 min per session, with a minimum interval of 4 h, under the supervision of their parents/guardians. They will wear DIMS spectacles for myopia correction during the day. Participants in the control group will not receive the RLRL therapy and will only wear DIMS spectacles to correct myopia. Participants from both groups will attend the hospital every 6 months. The primary outcome is the change in axial length at 12 months. Secondary outcomes include changes in refraction under cycloplegia, optical coherence tomography (OCT), multifocal electroretinogram (mfERG), color vision, and participants\' self-reporting of adverse events at 12 months.
CONCLUSIONS: This study will report the efficacy and safety outcome of the combination therapy of RLRL and DIMS versus DIMS for school-aged children with myopia in detail.
BACKGROUND: ChiCTR2300075398. Registered 4 September 2023. https://www.chictr.org.cn/bin/project/edit?pid=200751 .
METHODS: This study is a 12-month, randomized, parallel-controlled, single-center clinical trial. We will recruit children aged 8-12 years with spherical equivalence (SE) between - 0.50 D and - 6.00 D under cycloplegia in both eyes. We will recruit 66 participants with an allocation ratio of 1:1 from our hospital. Participants in the intervention group will be treated with an RLRL therapy device twice a day from Monday to Friday at home, 3 min per session, with a minimum interval of 4 h, under the supervision of their parents/guardians. They will wear DIMS spectacles for myopia correction during the day. Participants in the control group will not receive the RLRL therapy and will only wear DIMS spectacles to correct myopia. Participants from both groups will attend the hospital every 6 months. The primary outcome is the change in axial length at 12 months. Secondary outcomes include changes in refraction under cycloplegia, optical coherence tomography (OCT), multifocal electroretinogram (mfERG), color vision, and participants\' self-reporting of adverse events at 12 months.
CONCLUSIONS: This study will report the efficacy and safety outcome of the combination therapy of RLRL and DIMS versus DIMS for school-aged children with myopia in detail.
BACKGROUND: ChiCTR2300075398. Registered 4 September 2023. https://www.chictr.org.cn/bin/project/edit?pid=200751 .
摘要：
背景：近视在全球范围内的患病率正在增加。联合治疗对近视的控制效果优于单药治疗。已经报道了重复的低水平红光疗法(RLRL)疗法和结合散焦的多段(DIMS)眼镜镜片显著延缓近视进展。然而,这两种疗法是否比一种更好仍然是未知的。本研究旨在报告一项试验的研究方案，该试验旨在评估RLRL和DIMS联合治疗与DIMS单独治疗的有效性和安全性，以减少中国学龄儿童的近视进展。
方法：本研究为期12个月，随机化，并行控制，单中心临床试验。我们将招募8-12岁的儿童，其双眼在-0.50D和-6.00D之间的球形等效性（SE）。我们将从我院招募66名参与者，分配比例为1：1。干预组的参与者将在周一至周五的家中每天两次接受RLRL治疗设备的治疗，每节3分钟，最小间隔为4小时，在父母/监护人的监督下。他们将在白天佩戴DIMS眼镜进行近视矫正。对照组的参与者将不接受RLRL治疗，仅佩戴DIMS眼镜以矫正近视。两组参与者将每6个月到医院就诊。主要结果是12个月时轴向长度的变化。次要结果包括睫状肌麻痹下的屈光变化，光学相干断层扫描(OCT),多焦视网膜电图（mfERG），色觉,和参与者在12个月时的不良事件自我报告。
结论：本研究将详细报道RLRL和DIMS与DIMS联合治疗对近视学龄儿童的疗效和安全性结果。
背景：ChiCTR2300075398。2023年9月4日注册。https://www.chictr.org.cn/bin/project/edit?pid=200751。
方法：本研究为期12个月，随机化，并行控制，单中心临床试验。我们将招募8-12岁的儿童，其双眼在-0.50D和-6.00D之间的球形等效性（SE）。我们将从我院招募66名参与者，分配比例为1：1。干预组的参与者将在周一至周五的家中每天两次接受RLRL治疗设备的治疗，每节3分钟，最小间隔为4小时，在父母/监护人的监督下。他们将在白天佩戴DIMS眼镜进行近视矫正。对照组的参与者将不接受RLRL治疗，仅佩戴DIMS眼镜以矫正近视。两组参与者将每6个月到医院就诊。主要结果是12个月时轴向长度的变化。次要结果包括睫状肌麻痹下的屈光变化，光学相干断层扫描(OCT),多焦视网膜电图（mfERG），色觉,和参与者在12个月时的不良事件自我报告。
结论：本研究将详细报道RLRL和DIMS与DIMS联合治疗对近视学龄儿童的疗效和安全性结果。
背景：ChiCTR2300075398。2023年9月4日注册。https://www.chictr.org.cn/bin/project/edit?pid=200751。
