Using low-level red light to control myopia in children

An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression

This study is testing if low-level red light therapy can help slow down worsening eyesight in children aged 8-10 who have mild myopia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 8 Years to 10 Years
• Sex: All
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06717048 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Repeated Low-level Red-light (RLRL) therapy in controlling myopia progression in children aged 8-10 years with low myopia. The study aims to determine the optimal power and frequency of RLRL exposure and assess the rebound effect after discontinuation of treatment. Conducted as a prospective, double-blind, single-center, randomized controlled trial, it seeks to provide evidence for this innovative approach to myopia prevention and control. The trial addresses a significant public health concern, particularly in East Asia, where myopia is increasingly prevalent.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 8-10 years with low myopia, specifically those with spherical equivalent refractions ranging from -0.50 to -3.00 diopters.

Not a fit: Patients with secondary myopia, significant eye diseases, or systemic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to effectively manage and slow down myopia progression in children.

How similar studies have performed: While the use of RLRL for myopia control is a relatively novel approach, preliminary studies suggest potential effectiveness, warranting further investigation.

Eligibility criteria

Inclusion Criteria:

1. Age: 8-10 years old
2. Low myopia: cycloplegic spherical equivalent refractions (SERs) range from -0.50 (inclusive) to -3.00 diopters (D) and astigmatism less than -2.5 D in either eye.
3. signed informed consent and was able to participate in the study

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or other neonatal diseases; syndromic myopia with a known genetic disorder or connective tissue disease, such as Stickler syndrome or Marfan syndrome
2. Strabismus or other binocular vision abnormalities
3. Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
4. Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
5. History of refractive surgery, internal eye surgery, laser therapy, vitreous injection, etc.
6. diabetes, hypertension and other systemic disorders
7. History of use of retinal toxic drugs, such as hydroxychloroquine, etc.
8. Use of orthokeratology, atropine, multifocal frame glasses and other myopia control methods; children who are currently receiving atropine, orthokeratology, multifocal frame glasses and other myopia control treatment, can be enrolled after 2 weeks of treatment.
9. Other reasons considered unsuitable for inclusion by the study physician, including but not limited to other ocular and systemic disease abnormalities

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Eye Disease Prevention & Treatment Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Xiangui He, Prof

Conditions: Myopia, Refractive Error - Myopia, Choroidal Thickness, Retina