650nm Low-level Red-light for Myopia Control and Prevention in Children

Myopia Clinical Trial

Official title:

Repeated Exposure to 650nm Low-level Red-light for Myopia Control and Prevention in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786586
• Other study ID #: TongrenJY2022
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2023
• Est. completion date: December 2027

Study information

• Verified date: April 2023
• Source: Beijing Tongren Hospital
• Contact: Kai Cao
• Phone: 01058265900
• Email: caozhi[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 572
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• 650 nm low-level red-light
650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tongren Hospital	Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fundus injury related to 650 nm low-level red-light irridiation	Any potential fundus injury related to 650 nm low-level red-light irridiation would be checked through Fundus photography and coherence tomography examination	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
Primary	Change in axial length	Use an optical biometer to measure the 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
Primary	Change in spherical equivalent error	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.	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	Change in Choroid thickness	Use an enhanced-depth imaging technique (based on Optical coherence tomography )	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	Change in steep keratometry	Use an optical biometer	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	Change in flat keratometry	Use an optical biometer	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	Change in length thickness	Use an optical biometer	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	Change in anterior chamber depth	Use an optical biometer	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	Change in central corneal thickness	Use an optical biometer	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