An interventional study of Repeated low-level red light (RLRL) therapy in Myopia and Randomized Controlled Trial (RCT), sponsored by The First Affiliated Hospital of Anhui Medical University. Not yet recruiting. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by The First Affiliated Hospital of Anhui Medical University · Not applicable, Interventional, and Treatment
Myopia is a global public health issue, projected to affect 49.8% of the world population by 2050, increasing risks of cataracts, glaucoma, macular degeneration, and retinal detachment. Repeated low-level red light (RLRL) therapy has shown promising myopia control in 12-month trials, reducing axial elongation by 69.4% and refractive progression by 76.6% versus spectacles, outperforming 0.01% atropine and benefiting orthokeratology poor responders. However, two-year data indicate declining efficacy in the second year and a rebound effect upon discontinuation, with progression rates matching untreated controls. This study enrolls participants who completed one year of continuous RLRL therapy to evaluate rebound effects on axial length and spherical equivalent refractive power among those who discontinue, gradually reduce, or continue treatment. Findings will inform strategies to optimize long-term RLRL protocols and mitigate post-treatment rebound.
Myopia is a public health issue of global concern, with its incidence and severity increasing annually, particularly among children and adolescents. Projections indicate that by 2050, the global prevalence of myopia will reach as high as 49.8%, with the prevalence of high myopia reaching 9.8% .With the rising prevalence of myopia, the risk of myopia-related complications has increased significantly, including cataracts, glaucoma, myopic macular degeneration, and retinal detachment. Without proper management, these conditions can lead to severe visual impairment and substantial societal burdens. Therefore, preventing and slowing the onset and progression of myopia has become a critical strategy in myopia control efforts.
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. In a 12-month multicenter randomized clinical trial, the RLRL group demonstrated a 69.4% reduction in axial length elongation and a 76.6% decrease in myopic refractive progression compared to the single-vision spectacle (SVS) group. Furthermore, RLRL therapy showed superior efficacy in patients with high myopia, achieving an axial length reduction of over 0.05 mm in 53.3%-59% of cases.Comparative studies on the efficacy of atropine in controlling myopia demonstrated that, after 12 months of use, the RLRL therapy significantly outperformed 0.01% atropine in controlling axial length.In myopic patients who still exhibit poor control of axial length despite wearing orthokeratology lenses, combined use of RLRL therapy significantly inhibits axial growth.
Given that myopia typically progresses continuously during childhood, Xiong et al. investigated the long-term efficacy and safety of RLRL therapy over a period exceeding two years. The results demonstrated good tolerability of RLRL therapy, with an efficacy rate of 75% in terms of axial length reduction and myopic refractive control after two years of treatment; however, the therapeutic efficacy declined in the second year compared to the first year.Additionally, similar to other myopia intervention strategies, a rebound effect was observed in patients who discontinued RLRL treatment after one year; in these patients, their myopia progression rate during the second year was comparable to the progression level observed in the SVS group during its first year.
To further investigate the long-term efficacy of RLRL treatment and rebound effects after treatment discontinuation, as well as to explore strategies for mitigating these rebound effects, this study focused on participants who received continuous RLRL therapy for one year. It examined the rebound effects in axial length (AL) and spherical equivalent refractive power (SER) among participants who discontinued or gradually reduced RLRL treatment compared to those who continued treatment.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 159 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →The First Affiliated Hospital of Anhui Medical University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and continue to receive RLRL treatment for one more year.
Device: Repeated low-level red light (RLRL) therapy
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and discontinue RLRL treatment for one year.
Device: Repeated low-level red light (RLRL) therapy
The pediatric participants had received continuous Repeated low-level red light(RLRL) treatment for one year and gradually reduce the RLRL treatment for one year(First month: twice daily, for 5 days per week;Second month: Once daily, for 5 days per week;Third month: once daily, for 3 days per week).
Device: Repeated low-level red light (RLRL) therapy
Repeated low-level red light (RLRL) therapy is an emerging treatment modality for myopia control. The participants were randomly assigned to three groups: the continued RLRL treatment group (RLRL-C), the discontinued RLRL treatment group (RLRL-I), and the gradually reduced RLRL treatment group (RLRL-T).
Axial length(AL)
Change from baseline in Axial length \[Unit of Measure:mm\]
Time frame: Baseline, 6 months and12 months.
Change in Spherical Equivalent Refraction (SER)
Mean change from baseline in spherical equivalent refraction \[ Unit of Measure: Diopters (D) \]
Time frame: Baseline, 6 Months, 12 Months
Best-Corrected Visual Acuity (BCVA)
Change from baseline in best-corrected visual acuity measured using the ETDRS chart \[Unit of Measure: LogMAR\]
Time frame: Baseline, 6 Months, 12 Months
corneal curvature
Change from baseline in mean corneal curvature (K-readings) \[Unit of Measure: Diopters\]
Time frame: Baseline, 6 Months, 12 Months
Anterior Chamber Depth (ACD)
Change from baseline in anterior chamber depth (Unit of Measure:mm)
Time frame: Baseline,6 months and 12 months.
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Anhui Medical University