Multicenter RCT: LED Red Light Dose-Response in Myopia Progression Control

Condition(s) studied

Investigational drug(s) / intervention(s)

Yingtong Vision Rehabilitation Instrument: Input voltage: 6V (4 × 1.5V alkaline dry batteries). Red light wavelength: 650nm; light spot diameter: outer diameter 5.0mm, inner diameter 1.5mm. Light source output power: 1.6 mW (±0.1mW at 30mm from the observation window). The Yingtong Vision Rehabilitation Instrument should be used twice a day under the regular communication and supervision of hospital optometrists/coordinators (via phone, WeChat, etc.), with an interval of at least 4 hours.

Hoya DIMS multi-point myopia defocus lens: Frame glasses worn on the bridge of the nose

Study summary

The goal of this clinical trial is to verify the effectiveness and safety of non-laser LED red light combined with defocus lens therapy for controlling myopia progression and evaluate the impact of different intervention durations in 6-14 years old children and adolescents with myopia (spherical equivalent refraction: -6.00D ≤ SER ≤ -1.00D), regardless of gender. The main questions it aims to answer are:

\[primary hypothesis or outcome measure 1\]: Does the combination of Yingtong Vision Rehabilitation Instrument (non-laser LED red light) and Hoya DIMS defocus lens show non-inferior effectiveness to Hoya DIMS defocus lens alone in controlling 6-month axial length change? \[primary hypothesis or outcome measure 2\]: Do different single intervention durations (2min, 3min, 4min) of non-laser LED red light affect the effectiveness (e.g., axial length change at multiple time points, 12-month SER change) and safety of the combined therapy? If there is a comparison group: Researchers will compare Test Group A (2min PBM therapy + DIMS lenses), Test Group B (3min PBM therapy + DIMS lenses), Test Group C (4min PBM therapy + DIMS lenses), and Control Group D (DIMS lenses alone)\] to see if the combined therapy has similar or better myopia control effects and comparable safety, and to identify the optimal intervention duration.

Participants will:

Complete screening examinations (axial length, refractive error, visual acuity, IOP, fundus photography, OCT, etc.) and sign the informed consent form.

Be randomly assigned to one of the four groups and receive the corresponding intervention (use the Yingtong Vision Rehabilitation Instrument as per group-specific duration twice a day, with ≥4-hour interval, plus DIMS lenses; or only DIMS lenses).

Attend regular follow-up visits at 30 days, 3 months, 6 months, 9 months, and 12 months for efficacy and safety assessments (including repeated ocular examinations and adverse event reporting).

Cooperate with the entire 12-month trial process and comply with the device usage specifications and follow-up requirements.

Eligibility

Primary outcome measure(s)

• 6-month axial length change — 6-month
  The difference in axial length at 6 months after trial initiation compared with the baseline axial length

Trial sites (7)

More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China

Other trials for the same condition