Optometry and Vision Department, Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain.
ISEC LISBOA, Instituto Superior de Educação E Ciências, Lisbon, Portugal.
Trials. 2023 Oct 17;24(1):674. doi: 10.1186/s13063-023-07696-0.
Myopia prevalence has been increasing in the last decades, and its pathological consequences, including myopic maculopathy and high myopia-associated optic neuropathy, are now one of the most common causes of visual impairment. It is estimated that by 2050, more than 50% of Europeans and Americans will be myopes, which is alarming due to the high morbidity of myopes over - 6.00D. Once myopia has appeared, there are different options with scientific evidence to try to slow the axial length growth. Ophthalmic lenses are the less invasive treatment to control myopia, and there is evidence about the efficacy of different designs, mainly in the Asiatic population. However, new designs have been launched, and it is not known if efficacy is the same between Asiatic and European subjects. Thus, we have set up a randomized, controlled, double-blind, and multicenter trial to investigate the efficacy of a new design of ophthalmic lenses for myopia control in European children.
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. Three hundred children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between - 0.75D and - 5.00D, astigmatism < 1.50D, and anisometropia < 1.00D and having a historical evolution of at least - 0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
This study will be the first randomized and controlled clinical trial in European children with spectacle lenses based on simultaneous competing defocus. The results will shed light on the clinical evidence of spectacle lenses relying on this new design for the management of myopia with results of efficacy in the non-Asiatic population.
EU Clinical Trials Register (EudraCT) 2022-001696. Registered on 27 April 2022.
gov NCT05919654. Registered on 26 June 2023.
在过去几十年中，近视的患病率一直在增加，其病理后果，包括近视性黄斑病变和高度近视相关的视神经病变，现已成为视力损害的最常见原因之一。据估计，到 2050 年，超过 50%的欧洲人和美国人将成为近视者，这令人担忧，因为近视者的发病率超过-6.00D。一旦出现近视，就有不同的选择有科学证据试图减缓眼轴生长。眼科镜片是控制近视的侵入性较小的治疗方法，有证据表明不同设计的疗效主要在亚洲人群中。然而，已经推出了新的设计，尚不清楚亚洲和欧洲受试者之间的疗效是否相同。因此，我们设立了一项随机、对照、双盲、多中心试验，以调查一种新的眼科镜片设计在欧洲儿童中控制近视的疗效。
采用前瞻性、多中心、随机对照、双盲临床试验，研究一种新的眼科镜片设计减缓近视进展的疗效。将招募 300 名 6 至 13 岁的儿童，并随机分为研究组和对照组。研究组由 150 名佩戴 MyoCare 的儿童组成，对照组由 150 名佩戴 Clearview 的儿童组成。纳入标准为等效球镜度在-0.75D 至-5.00D 之间的近视、散光<1.50D 且双眼屈光参差<1.00D，且有至少-0.50D 的历史演变。主要结局是比较两组等效球镜度的年平均进展。次要结局为两组眼轴长度、脉络膜厚度、斜视和调节状态。
这将是第一项基于同时竞争离焦的欧洲儿童使用眼镜的随机对照临床试验。研究结果将为基于这种新设计管理近视的眼镜的临床证据提供依据，为非亚洲人群的疗效提供结果。
欧盟临床试验注册处（EudraCT）2022-001696。2022 年 4 月 27 日注册。
gov NCT05919654。2023 年 6 月 26 日注册。
