Actively Recruiting
An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression
Led by Shanghai Eye Disease Prevention and Treatment Center · Updated on 2024-12-04
108
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the minimum power and frequency of Repeated Low-level Red-light (RLRL) therapy needed to control myopia progression in children aged 8 to 10 years with low myopia. The study also examines the rebound effect on myopia progression after stopping RLRL treatment with different combinations of power and frequency. This prospective, double-blind, randomized controlled trial aims to provide clearer evidence on how RLRL exposure can best prevent worsening of myopia, a condition linked to serious eye complications. Participants will use a low-intensity red light device alongside their regular single vision spectacle lenses. The treatment is given Monday to Friday with sessions lasting 3 minutes, spaced by at least 4 hours. Various groups will receive different power levels and frequencies of red light, ranging from 0.3 mW to 2.0 mW once or twice daily, while a control group will receive a sham red LED treatment twice daily. This setup helps assess how changes in treatment dose affect myopia control. Throughout the study, children's eye measurements will be closely monitored at multiple time points including 1 week, 1, 2, 3, and 4 months. Assessments include axial length and refractive error measurements, visual acuity, choroidal thickness, and retinal function tests. Researchers will also track any side effects such as glare or afterimages. The primary outcome is the percentage of participants with minimal axial length increase after 3 months of treatment, with additional follow-up after treatment stops to observe any rebound effects.
CONDITIONS
Brief Title
Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and 10 years old
- Low myopia with cycloplegic spherical equivalent refraction from -0.50 to -3.00 diopters
- Astigmatism less than -2.5 diopters in either eye
- Signed informed consent and ability to participate in the study
You will not qualify if you...
- Secondary myopia from conditions like retinopathy of prematurity or genetic disorders such as Stickler or Marfan syndrome
- Strabismus or other binocular vision problems
- Cloudy refractive media including cloudy cornea, cataract, or previous intraocular lens surgery
- Eye diseases affecting retinal function such as macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, endophthalmitis, uveitis, or optic neuropathy
- History of refractive or internal eye surgery, laser therapy, or vitreous injection
- Systemic diseases like diabetes or hypertension
- Use of retinal toxic drugs such as hydroxychloroquine
- Current or recent use of orthokeratology, atropine, multifocal glasses, or other myopia control treatments unless stopped for at least 2 weeks
- Other ocular or systemic diseases deemed unsuitable by the study physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 3 months
Participants receive repeated low-level red-light therapy with varying power and frequency alongside single vision spectacle lenses to control myopia progression.
Weekly visits for assessments during treatment
Duration - 1 month
Participants are monitored for changes in axial length, refraction, and eye health after stopping red-light therapy.
1 visit at the end of follow-up period
Trial Site Locations
Total: 1 location
1
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, China, 200041
Actively Recruiting
Research Team
X
Xiangui He, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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