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

Официальное название

Multicenter, Open-Label, Parallel-Group, Randomized Controlled Study Comparing the Dose-Response Relationship of LED Red Light in Controlling Myopia Progression

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 6-month axial length change [Срок оценки: 6-month]

Вторичные конечные точки (2)

• 1-, 3-, 9- and 12-month axial length changes [Срок оценки: 1-, 3-, 9- and 12-month]
• 12-month spherical equivalent refraction (SER) change [Срок оценки: 12-month]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The Second People's Hospital of Foshan City — Foshan
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and — Ухань
• The Fourth People's Hospital of Shenyang City — Шэньян
• The First Affiliated Hospital of Guangxi Medical University — Guilin
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an

Публикации

• He M, Zeng J, Liu Y, Xu J, Pokharel GP, Ellwein LB. Refractive error and visual impairment in urban children in southern china. Invest Ophthalmol Vis Sci. 2004 Mar;45(3):793-9. doi: 10.1167/iovs.03-1051. PMID 14985292
• Zhao J, Pan X, Sui R, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from Shunyi District, China. Am J Ophthalmol. 2000 Apr;129(4):427-35. doi: 10.1016/s0002-9394(99)00452-3. PMID 10764849
• Maul E, Barroso S, Munoz SR, Sperduto RD, Ellwein LB. Refractive Error Study in Children: results from La Florida, Chile. Am J Ophthalmol. 2000 Apr;129(4):445-54. doi: 10.1016/s0002-9394(99)00454-7. PMID 10764851
• Pokharel GP, Negrel AD, Munoz SR, Ellwein LB. Refractive Error Study in Children: results from Mechi Zone, Nepal. Am J Ophthalmol. 2000 Apr;129(4):436-44. doi: 10.1016/s0002-9394(99)00453-5. PMID 10764850
• Mutti DO, Hayes JR, Mitchell GL, Jones LA, Moeschberger ML, Cotter SA, Kleinstein RN, Manny RE, Twelker JD, Zadnik K; CLEERE Study Group. Refractive error, axial length, and relative peripheral refractive error before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2007 Jun;48(6):2510-9. doi: 10.1167/iovs.06-0562. PMID 17525178
• Zadnik K, Sinnott LT, Cotter SA, Jones-Jordan LA, Kleinstein RN, Manny RE, Twelker JD, Mutti DO; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Prediction of Juvenile-Onset Myopia. JAMA Ophthalmol. 2015 Jun;133(6):683-9. doi: 10.1001/jamaophthalmol.2015.0471. PMID 25837970
• Zhang M, Gazzard G, Fu Z, Li L, Chen B, Saw SM, Congdon N. Validating the accuracy of a model to predict the onset of myopia in children. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5836-41. doi: 10.1167/iovs.10-5592. PMID 21330664
• Jones-Jordan LA, Sinnott LT, Manny RE, Cotter SA, Kleinstein RN, Mutti DO, Twelker JD, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Early childhood refractive error and parental history of myopia as predictors of myopia. Invest Ophthalmol Vis Sci. 2010 Jan;51(1):115-21. doi: 10.1167/iovs.08-3210. Epub 2009 Sep 8. PMID 19737876

Идентификаторы

NCT: NCT07330180 · 20251009041118960

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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