State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Department of Ophthalmology, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Baden-Württemberg, Germany.
BMJ Open. 2020 Dec 30;10(12):e039183. doi: 10.1136/bmjopen-2020-039183.
Myopic maculopathy and glaucoma belong to the most common causes of irreversible blindness worldwide and, having an ocular axial elongation as one of their main risk factors, can occur together. The detection of glaucomatous optic neuropathy (GON) in highly myopic eyes is clinically and technically difficult, and there is no information available, neither about the natural course of GON or about the course of GON under intraocular pressure-lowering therapy. We therefore designed this study to explore the natural course of GON in highly myopic eyes.
In this single-centred longitudinal registry cohort study, 813 highly myopic individuals will be recruited and undergo detailed ophthalmic examinations. High myopia is defined by a myopic refractive error of ≥-6 D or an axial length of ≥26.5 mm. GON is defined by a glaucomatous appearance of the optic nerve head or glaucomatous visual field (VF) defects. GON progression is defined by either change of the optic disc or VF.
Ethical approval has been obtained from the ethical committee of the Zhongshan Ophthalmic Center (ZOC), Sun Yat-sen University, China (ID: 2019KYPJ079). All the participants are required to provide informed consents. Results will be disseminated through scientific meetings and published in peer-reviewed journals. The data will be deposited at the clinical research centre in ZOC using electronic data capture system, and a copy of paper files will also be kept. Only members of the project team will have access to these data.
NCT04302220.
近视性黄斑病变和青光眼属于全球最常见的致盲原因，它们的主要危险因素之一是眼球轴长增加，因此这两种疾病可能同时发生。高度近视眼的青光眼性视神经病变（GON）的临床和技术检测都具有一定难度，目前尚无关于 GON 自然病程或眼压降低治疗下 GON 病程的信息。因此，我们设计了这项研究，旨在探索高度近视眼中 GON 的自然病程。
在这项单中心纵向登记队列研究中，将招募 813 名高度近视个体并进行详细的眼科检查。高度近视定义为近视屈光不正≥-6D 或眼轴长度≥26.5mm。GON 定义为视神经头的青光眼表现或青光眼视野（VF）缺损。GON 进展定义为视盘或 VF 的变化。
中山大学中山眼科中心（ZOC）伦理委员会已批准该研究（ID：2019KYPJ079）。所有参与者均需提供知情同意书。研究结果将通过科学会议和同行评议期刊发表。数据将使用电子数据采集系统存储在 ZOC 的临床研究中心，并保留一份纸质文件的副本。只有项目团队成员可以访问这些数据。
NCT04302220。
