ArticleTrials2024
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.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Repeated low-intensity red light therapy for childhood myopia: a retrospective cohort study.American journal of translational research · 2025Article
- Repeated low-level red-light therapy for myopia control: An update on efficacy and safety.Taiwan journal of ophthalmologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundMyopia 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.
methodsThis 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. 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 registrationChiCTR2300075398. Registered 4 September 2023. https://www.chictr.org.cn/bin/project/edit?pid=200751 .
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