Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children

Официальное название

Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children.

Обзор

This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.

Подробное описание

Myopia now is recognized as one of the important public health problems and myopia prevention and control has become more important. Various myopia management strategies have been tested in the past for the control of myopia progression in children. In recent years, various optical interventions have also been explored to manage myopia, including the use of optical, pharmaceutical, and lifestyle interventions. Spectacles, atropine eye drops, and outdoor activities have shown some efficacy in slowing myopia progression, but the optimal approach to delaying or preventing the onset of myopia in at-risk populations remains a challenge. These myopia management modalities are often also labelled as invasive and non-invasive methods. One of the non-invasive myopia management modalities includes spectacles.

DIMS spectacle lenses are based on creating myopic defocus at the mid-periphery of the retina which would provide a cue of axial length elongation control. DIMS is a spectacle lens with a central optical zone of 9.4 mm for correcting distance myopic refractive errors and a mid-peripheral 33mm of treatment zone with multiple segments of 1 mm diameter, each segment provides defocus of + 3.5D. 2-year Randomised Controlled Trial (RCT) showed 52% reduction in myopia progression and 62% slow down effect in axial elongation in children wearing DIMS spectacle lenses compared to those on single vision spectacle lens correction at the end of 2-year follow-up in Hong Kong children.

2-years RCT has been conducted using DIMS clear spectacle lenses, however, no studies have been conducted on photochromic and polarized version to show the non-inferiority of sun solutions compared to clear version in myopia management.

This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.

Вмешательства

• Устройство EYE001
  Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Первичные конечные точки

• Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS) [Срок оценки: 24 months]

Вторичные конечные точки (1)

• Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) [Срок оценки: 24 months]

Критерии участия

Критерии включения

Subjects must meet all the criteria listed to participate in the study:

• All ethnicities
• Age between 6 and 15 years
• Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D
• Anisometropia ≤ 3.00D
• Best corrected monocular distance high contrast VA ≤ 0.10 logMAR
• Normal Binocular vision (fusion and stereopsis)

Критерии исключения

All subjects meeting any of the exclusion criteria at baseline will be excluded from participation:

• Ocular and systemic abnormalities
• Children who do not cooperate
• Binocular vision anomalies (strabismus, suppression)
• Previous use of myopia management treatment (spectacles, atropine, CLs)
• Neurological disorders
• Premature infants
• Children who do not wear their glasses correctly for intermediate and near vision activities
• Children who do not meet the inclusion criteria
• No informed consent given by parents of child for participation in the clinical study
• Subject is allergic to cycloplegic eye drops

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Singapore National Eye Centre — Singapore

Публикации

• Lam CS, Tang WC, Lee PH, Zhang HY, Qi H, Hasegawa K, To CH. Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study. Br J Ophthalmol. 2022 Aug;106(8):1110-1114. doi: 10.1136/bjophthalmol-2020-317664. Epub 2021 Mar 17. PMID 33731364
• Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29. PMID 31142465

Идентификаторы

NCT: NCT06717035 · SingaporeNEC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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