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

Sponsor
The First Affiliated Hospital of Anhui Medical University
Study ID
NCT07748546
Status
Not Yet Recruiting

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Conditions

  • Myopia
  • Randomized Controlled Trial (RCT)

Eligibility Criteria

Sex
ALL
Age
8 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jul 15, 2028

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.
  • 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).

Primary Outcome Measure

Axial length(AL) [ Time Frame: Baseline, 6 months and12 months. ]

Central Contacts

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