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NCT Number: NCT07748546

The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 8 to 16 years old
  • Rceived continuous RLRL treatment for 1 year (±1 month) without interruption.
  • Diagnosed with myopia (ciliary muscle paralysis SER ≥ -0.50 D), astigmatism ≤ 2.50 D, anisometropia ≤ 1.50 D, and bilateral best corrected visual acuity (BCVA) ≥ Snellen 20/20 before receiving RLRL treatment.
  • The consent of the guardian and the consent of the participant.

Exclusion criteria

  • History of any ophthalmic surgery or ocular diseases (e.g., glaucoma, retinal disorders).
  • Systemic diseases that affect vision or eye health (e.g., diabetes). After discontinuing RLRL treatment, other myopia control interventions other than monocular glasses should be employed (including atropine, orthokeratology lenses, defocused/DOT lenses, etc.).

Treatment and study plan

Repeated Low-Level Red Light (RLRL) therapy

Device

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).

Primary outcomes

  1. Axial length(AL)

    Time frame: Baseline, 6 months and12 months.

    Change from baseline in Axial length [Unit of Measure:mm]

Secondary outcomes

  1. Change in Spherical Equivalent Refraction (SER)

    Time frame: Baseline, 6 Months, 12 Months

    Mean change from baseline in spherical equivalent refraction [ Unit of Measure: Diopters (D) ]

  2. Best-Corrected Visual Acuity (BCVA)

    Time frame: Baseline, 6 Months, 12 Months

    Change from baseline in best-corrected visual acuity measured using the ETDRS chart [Unit of Measure: LogMAR]

  3. corneal curvature

    Time frame: Baseline, 6 Months, 12 Months

    Change from baseline in mean corneal curvature (K-readings) [Unit of Measure: Diopters]

  4. Anterior Chamber Depth (ACD)

    Time frame: Baseline,6 months and 12 months.

    Change from baseline in anterior chamber depth (Unit of Measure:mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Lixia Feng, Doctor

CONTACT

[email protected]

+8613075590585

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia: A Randomized Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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