CompletedNot Applicable

The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial

China192 participantsStarted 2021-02-04

Plain-language summary

Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents. Methods: Subject population: Children aged 3-16 years who have high myopia. Sample size: 190 subjects were planned to be enrolled and assigned to the test or control group in a 1:1 ratio.

Who can participate

Age range3 Years – 16 Years

SexALL

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Inclusion criteria

✓. age 3 to 16 years (inclusive), male or female
✓. clinical diagnosis confirming that myopia has occurred in at least one eye.
✓. the guardian voluntarily signed the "Subject's Informed Consent Form"

What they're measuring

Axial length changes

Timeframe: 30± 14 days, 90± 14 days, 180± 14 days, 270± 14 days, and 365± 14 days

Trial details

NCT IDNCT05184621

SponsorShanghai Eye Disease Prevention and Treatment Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-15

View on ClinicalTrials.gov More Age 3 to 16 Years (Inclusive), Male or Female trials