The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorThe First Affiliated Hospital of Anhui Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
Repeated low-level red light (RLRL) therapy
DeviceRepeated 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).
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: the continued RLRL treatment group(RLRL-C)Active comparator 1 intervention
Group B: the discontinued RLRL treatment group (RLRL-I)Experimental treatment 1 intervention
Group C: the gradually reduced RLRL treatment group (RLRL-T)Experimental treatment 1 intervention
Trial outcomes
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 Months2
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 Months3
corneal curvature
Change from baseline in mean corneal curvature (K-readings) \[Unit of Measure: Diopters\]
Time frame
Baseline, 6 Months, 12 Months4
Anterior Chamber Depth (ACD)
Change from baseline in anterior chamber depth (Unit of Measure：mm)
Time frame
Baseline,6 months and 12 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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