Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for
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STUDY PROTOCOL
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Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial Feng Bin Lin1†, Shi Da Chen1†, Yun He Song1, Wei Wang1, Ling Jin1, Bing Qian Liu1, Yu Hong Liu1, Mei Ling Chen1, Kai Gao1, David S. Friedman2, Jost B. Jonas3, Tin Aung4, Lin Lv1, Yi Zhi Liu1, Xiu Lan Zhang1* and on behalf of the GSHM study group
Abstract Background: Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods: The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion: To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration: ClinicalTrials.gov NCT04296916. Registered on 4 March 2020 Keywords: Glaucoma suspect, High myopia, Intraocular pressure, Randomized controlled trial
* Correspondence: [email protected] † Feng Bin Lin and Shi Da Chen are joint first authors. 1 State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.7, Jinsui Road, Guangzhou 510060, China Full list of author information is available at the end of the article © The
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