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

NCT07748546 | Not Yet Recruiting DMC

• 1 other identifier: KY2026-03-88
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myopia; Randomized Controlled Trial (RCT)

Keywords

myopia; randomized controlled trial; therapy

Outcome Measures

Primary Outcomes (1)

• Axial length(AL)

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

  Baseline, 6 months and12 months.

Secondary Outcomes (4)

• Change in Spherical Equivalent Refraction (SER)

  Baseline, 6 Months, 12 Months

• Best-Corrected Visual Acuity (BCVA)

  Baseline, 6 Months, 12 Months

• corneal curvature

  Baseline, 6 Months, 12 Months

• Anterior Chamber Depth (ACD)

  Baseline,6 months and 12 months.

Study Arms (3)

the continued RLRL treatment group(RLRL-C)

ACTIVE COMPARATOR

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 discontinued RLRL treatment group (RLRL-I)

EXPERIMENTAL

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 gradually reduced RLRL treatment group (RLRL-T)

EXPERIMENTAL

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

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).

the continued RLRL treatment group(RLRL-C); the discontinued RLRL treatment group (RLRL-I); the gradually reduced RLRL treatment group (RLRL-T)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

MeSH Terms

Conditions

Myopia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Lixia Feng, Doctor

CONTACT

+8613075590585; lixiafeng75@fy.ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 5, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share