Myopia, Myopia, Progressive
Conditions
Keywords
Myopia, Children, Axial Length, Red-light Therapy
Brief 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.
Interventions
DEVICEYingtong 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.
DEVICEHoya DIMS multi-point myopia defocus lens
Frame glasses worn on the bridge of the nose
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 6 to 14 years old, regardless of gender; * After cycloplegic autorefraction, monocular or binocular spherical equivalent refraction (SER) meets: -6.00D ≤ SER ≤ -1.00D, and binocular best-corrected visual acuity (BCVA) ≥ 0.8 (logMAR 0.1; Snellen 20/25); * Binocular anisometropia ≤ 1.50D; astigmatism ≤ 2.50D; * Able to understand the purpose of the study, willing to participate in this clinical verification, sign the informed consent form personally or through their legal guardian, and cooperate with the entire trial process (12 months).
Exclusion criteria
* Photophobia or allergy to cycloplegic agents (e.g., tropicamide or cyclopentolate); * Received any of the following myopia control measures within one month (including but not limited to): low-concentration atropine eye drops, orthokeratology lenses, myopia control-related frame glasses, low-level red light therapy, defocus soft contact lenses, or defocus RGP lenses; * Subjects with ocular diseases that may affect visual acuity or refractive error (e.g., lens disorders such as cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, etc.); * Neurological diseases (previous convulsion history, epilepsy, tic disorders, central nervous system developmental abnormalities) or mental and psychological diseases; * Systemic diseases: immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary function impairment, severe liver and kidney dysfunction, acute or chronic sinusitis, or diabetes mellitus; * Binocular manifest strabismus or any other pathological changes of the eyeball or acute inflammatory ocular diseases; * Subjects deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month axial length change | 6-month | The difference in axial length at 6 months after trial initiation compared with the baseline axial length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-, 3-, 9- and 12-month axial length changes | 1-, 3-, 9- and 12-month | The difference in axial length at 1-, 3-, 9- and 12-month after trial initiation compared with the baseline axial length |
| 12-month spherical equivalent refraction (SER) change | 12-month | The difference in spherical equivalent refraction at 12-month after trial initiation compared with the baseline spherical equivalent refraction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate and serious adverse event rate | 1-, 3-, 6-, 9- and 12-month | Adverse event rate and serious adverse event rate |
| 12-month visual adverse event rate | 12-month | BVCA decrease ≥0.2 logMAR |
Countries
China
Contacts
Primary ContactXiaojuan Wang, Doctor
Outcome results
None listed