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Not yet recruitingNCT07748546Updated Aug 5, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
8 Years to 16 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Myopia
  • Randomized Controlled Trial (RCT)

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Keywords

  • myopia
  • randomized controlled trial
  • therapy
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In context

Myopia

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 →

Lead sponsor

The First Affiliated Hospital of Anhui Medical University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 8 to 16 years old
  2. Rceived continuous RLRL treatment for 1 year (±1 month) without interruption.
  3. 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.
  4. The consent of the guardian and the consent of the participant.

Exclusion criteria

Exclusion Criteria:

  1. History of any ophthalmic surgery or ocular diseases (e.g., glaucoma, retinal disorders).
  2. 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.).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
159 participants (estimated)

Study arms

  • Active comparator
    the continued RLRL treatment group(RLRL-C)

    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

  • Experimental
    the discontinued RLRL treatment group (RLRL-I)

    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

  • Experimental
    the gradually reduced RLRL treatment group (RLRL-T)

    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

Interventions

  • DeviceRepeated 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).

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What researchers measure

Primary outcomes

  1. Axial length(AL)

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

    Time frame: Baseline, 6 months and12 months.

Secondary outcomes

  1. 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

  2. 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

  3. corneal curvature

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

    Time frame: Baseline, 6 Months, 12 Months

  4. Anterior Chamber Depth (ACD)

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

    Time frame: Baseline,6 months and 12 months.

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07748546
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Responsible party
Lixia Feng (chief physician, The First Affiliated Hospital of Anhui Medical University) — Principal investigator
First posted
Aug 5, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jul 15, 2028 (estimated)
Last update
Aug 5, 2026

Study contacts

Lixia Feng, Doctor
Contact
lixiafeng75@fy.ahmu.edu.cn
+8613075590585

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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