Clinical trial NCT05832723: A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents
Official title: A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 7-18 years, and is willing to use 650 nm low-level red-light to control or prevent myopia.

Brief summary: To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 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 real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. 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:

1. Children aged 7 to 18 years
2. The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
3. Astigmatism of 2.5 D or less (≤2.5D)
4. Willing to participate in the study and sign the informed consent form

Exclusion Criteria:

1. Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
2. Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
3. Mental diseases
4. Similar interventions have been used in the past year
5. Allergic to cycloplegic agents or to red light
6. The 650nm red light intervention was not suitable for the condition evaluated by the researchers
7. are currently using atropine or similar drugs, or have stopped using them for less than 1 month

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