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

2 augustus 2026 bijgewerkt door: Lixia Feng, The First Affiliated Hospital of Anhui Medical University

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

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

159

Fase

  • Niet toepasbaar

Contacten en locaties

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Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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:

  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.).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
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).
Experimenteel: 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.
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).
Experimenteel: 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).
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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Axial length(AL)
Tijdsspanne: Baseline, 6 months and12 months.
Change from baseline in Axial length [Unit of Measure:mm]
Baseline, 6 months and12 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Spherical Equivalent Refraction (SER)
Tijdsspanne: Baseline, 6 Months, 12 Months
Mean change from baseline in spherical equivalent refraction [ Unit of Measure: Diopters (D) ]
Baseline, 6 Months, 12 Months
Best-Corrected Visual Acuity (BCVA)
Tijdsspanne: Baseline, 6 Months, 12 Months
Change from baseline in best-corrected visual acuity measured using the ETDRS chart [Unit of Measure: LogMAR]
Baseline, 6 Months, 12 Months
corneal curvature
Tijdsspanne: Baseline, 6 Months, 12 Months
Change from baseline in mean corneal curvature (K-readings) [Unit of Measure: Diopters]
Baseline, 6 Months, 12 Months
Anterior Chamber Depth (ACD)
Tijdsspanne: Baseline,6 months and 12 months.
Change from baseline in anterior chamber depth (Unit of Measure:mm)
Baseline,6 months and 12 months.

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 augustus 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

15 juli 2028

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 augustus 2026

Eerst geplaatst (Werkelijk)

5 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KY2026-03-88

Plan Individuele Deelnemersgegevens (IPD)

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JA

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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