650nm Low-level Red-light for Myopia Control and Prevention in Children
- Conditions
- Myopia
- Interventions
- Device: 650 nm low-level red-light
- Registration Number
- NCT05786586
- Lead Sponsor
- Beijing Tongren Hospital
- Brief Summary
A multicenter randomized controlled trial, evaluating the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children. Participants included children(aged 6 to 12 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
- Detailed Description
This multicenter randomized controlled trial will be conducted in three hospitals: Beijing Tongren Hospital, and another two subcenters. The whole study will last for five years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up and the end of the study. The intervention measure used will be 650 nm low-level red-light. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 572
- Children aged 6 to 12 years
- The cycloplegic spherical equivalent error (SER) is -6D to 1D (> -6D, ≤1D) in both eyes
- Astigmatism of 2.5 D or less (≤2.5D)
- Willing to participate in the study and sign the informed consent form
- Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens
- With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia
- With refractive media opacification (keratopathy, lens opacity, etc.)
- Allergy to cycloplegia drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 650 nm low-level red-light, plus single vision spectacle lenses 650 nm low-level red-light Children in the treatment group are expected to receive 6 minutes irradiation of 650 nm low-level red-light daily, divided into two times a day, each lasting for 3 minutes. Single vision spectacle lenses are allowed for myopic children.
- Primary Outcome Measures
Name Time Method Change in axial length Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an optical biometer to measure the axial length.
Change in spherical equivalent error Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.
- Secondary Outcome Measures
Name Time Method Change in Choroid thickness Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an enhanced-depth imaging technique (based on Optical coherence tomography )
Change in steep keratometry Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an optical biometer
Change in flat keratometry Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an optical biometer
Change in length thickness Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an optical biometer
Change in anterior chamber depth Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an optical biometer
Change in central corneal thickness Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up Use an optical biometer
Trial Locations
- Locations (1)
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China