Clinical trial NCT05786586: 650nm Low-level Red-light for Myopia Control and Prevention in Children
Official title: Repeated Exposure to 650nm Low-level Red-light for Myopia Control and Prevention in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
name: Children's Hospital of The Capital Institute of Pediatrics
First posted: 2023-03-27
Enrollment: 572
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in axial length
timeFrame: 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
measure: Change in spherical equivalent error
timeFrame: 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
Secondary outcomes:
measure: Change in Choroid thickness
timeFrame: 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
measure: Change in steep keratometry
timeFrame: 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
measure: Change in flat keratometry
timeFrame: 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
measure: Change in length thickness
timeFrame: 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
measure: Change in anterior chamber depth
timeFrame: 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
measure: Change in central corneal thickness
timeFrame: 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
Other outcomes:
measure: Fundus injury related to 650 nm low-level red-light irridiation
timeFrame: 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
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Ying Jie
role: PRINCIPAL_INVESTIGATOR
References: