The efficacy and safety of combination therapy of repeated low-level red light and defocus-incorporated multiple segments spectacle lenses for myopia control in children: the study protocol for a 12-month, randomized, parallel-controlled, and single-center clinical trial.

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 11 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. DISCUSSION: 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. TRIAL REGISTRATION ChiCTR2300075398. Registered 4 September 2023. https//www.chictr.org.cn/bin/project/edit?pid=200751 .