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
The catalytic hydrolysis of Bis(p-nitrophenyl) phosphate ester (BNPP) in the metallomicelle made up of Ce3+-diethylenetriamine and LSS (N-lauroyl sarcosinate) was investigated by UV/VIS method. The effect of the catalytic efficiency and stability of the system was studied under the different conditions. The results indicated that the catalytic system exhibited high activity, stability and reproducibility in the BNPP catalytic hydrolysis under proper proportion of Ce3+ion and diethylenetriamine, pH and temperature when the concentration of LSS is higher than its CMC (critical micelle concentration). The results also showed that the active species is the complex made up of Ce3+ion and diethylenetriamine.
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