Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Feng Bin Lin, Shi Da Chen, Yun He Song, Wei Wang, Ling Jin, Bing Qian Liu, Yu Hong Liu, Mei Ling Chen, Kai Gao, David S Friedman, Jost B Jonas, Tin Aung, Lin Lv, Yi Zhi Liu, Xiu Lan Zhang, GSHM study group, Xiu Lan Zhang, Yi Zhi Liu, Lin Lv, David S Friedman, Jost B Jonas, Tin Aung, Shi Da Chen, Wei Wang, Feng Bin Lin, Yun He Song, Fei Li, Kai Gao, Bing Qian Liu, Yu Hong Liu, Mei Ling Chen, Neil M Bressler, Ki Ho Park, Ming Guang He, Ching-Yu Cheng, Paul Healey, Xiang Chen, Guang Xian Tang, Ling Jin, Feng Bin Lin, Shi Da Chen, Yun He Song, Wei Wang, Ling Jin, Bing Qian Liu, Yu Hong Liu, Mei Ling Chen, Kai Gao, David S Friedman, Jost B Jonas, Tin Aung, Lin Lv, Yi Zhi Liu, Xiu Lan Zhang, GSHM study group, Xiu Lan Zhang, Yi Zhi Liu, Lin Lv, David S Friedman, Jost B Jonas, Tin Aung, Shi Da Chen, Wei Wang, Feng Bin Lin, Yun He Song, Fei Li, Kai Gao, Bing Qian Liu, Yu Hong Liu, Mei Ling Chen, Neil M Bressler, Ki Ho Park, Ming Guang He, Ching-Yu Cheng, Paul Healey, Xiang Chen, Guang Xian Tang, Ling Jin

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.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic of the GSHM study design
Fig. 2
Fig. 2
The schematic of the intervention design
Fig. 3
Fig. 3
The schedule of enrollment, interventions, and assessments

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