Dataset Information

Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: A Randomized Controlled Trial

ABSTRACT: Abstract

Aim and objective

Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.

Materials and methods

In this randomized controlled trial, patients with normal eye exams were randomly assigned to receive, in a randomly selected eye, one drop of either balanced salt solution (BSS) or dexmedetomidine (0.0055%). Goldmann applanation tonometry was performed at baseline and then 30 minutes, 4 hours, and 24 hours after drop instillation.

Results

Forty-nine eyes of 49 normal volunteers were enrolled in the study, with 21 eyes (group I) receiving BSS and 28 (group II) dexmedetomidine. Both groups were comparable at baseline as far as age and IOP (p = 0.55 for both parameters). Intraocular pressure significantly decreased from baseline in group II at 30 minutes and 4 hours (p = 0.001 and 0.05, respectively). Maximum IOP decrease was obtained at 30 minutes after dexmedetomidine instillation, with a 9% decrease from baseline (mean decrease: 1.15 mm Hg). The percentage of IOP decrease was significantly higher in group II at 30 minutes compared with group I (9 vs 1.1%; p = 0.05). No side effects were recorded.

Conclusion

In this pilot study, dexmedetomidine 0.0055% drops have shown good safety and efficacy in lowering IOP in normal healthy volunteers with no history of glaucoma. This medication has a short onset of action, with a 10% reduction of IOP occurring 30 minutes post-instillation.

Trial registration number

NCT03690622.

How to cite this article

Fakhoury H, Abdelmassih Y, El-Khoury S, et al. The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: A Randomized Controlled Trial. J Curr Glaucoma Pract 2021;15(2):58–63.

SUBMITTER: Fakhoury H

PROVIDER: S-EPMC8543749 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description: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.