Abstract | PURPOSE: DESIGN: Double-masked, randomized controlled trial of hyperosmolar eye drops. PARTICIPANTS: METHODS: One eye was randomized to hyperosmolar eye drops (treatment); the fellow eye was randomized to artificial tears (placebo). After baseline examination in the afternoon, corneas were examined using Scheimpflug tomography after eye opening in the morning. Participants received eye drops twice. Imaging was repeated every 30 minutes up to 4 hours. MAIN OUTCOME MEASURES: Decrease in central corneal thickness 1 hour after eye opening (primary end point), corneal thickness, subjective visual function, glare, visual acuity, and adverse events (AEs) (secondary end points). RESULTS: A total of 68 participants received the allocated intervention (59 eyes received treatment; 55 eyes received placebo). All eyes had stromal edema; none had epithelial edema. Corneal thickness was 626 μm in the treatment arm and 622 μm in the placebo arm after eye opening, indicating an early morning edema compared with baseline of +21 μm and +24 μm, respectively. Decrease in corneal thickness after 1 hour was -10.5 μm in the treatment arm (95% confidence interval [CI], -12.8 to -8.2) and -11.2 μm (95% CI, -13.6 to -8.9) in the placebo arm (between-arm difference, 0.7 μm, 95% CI, -2.0 to 3.5; P = 0.59), indicating no clinically relevant effect of hyperosmolar eye drops on early morning corneal edema. Results were not compatible with a relevant treatment effect on corneal thickness, visual acuity, and glare over the entire course of the study. Increase in subjective visual function was less rapid in the treatment arm than in the placebo arm. Adverse events, most commonly burning after eye drop application, were more common with treatment (30 eyes) than placebo (1 eye; risk difference, 49 percentage points; 95% CI, 36-62). CONCLUSIONS: In this double-masked, randomized controlled trial, resolution of early morning stromal edema was not accelerated by hyperosmolar eye drops, which more frequently caused AEs. These results are not compatible with a clinically relevant effect of hyperosmolar eye drops and do not support their routine use.
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Authors | Daniel B Zander, Daniel Böhringer, Marianne Fritz, Viviane Grewing, Philip C Maier, Thabo Lapp, Thomas Reinhard, Katrin Wacker |
Journal | Ophthalmology
(Ophthalmology)
Vol. 128
Issue 11
Pg. 1527-1533
(11 2021)
ISSN: 1549-4713 [Electronic] United States |
PMID | 33892048
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
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Topics |
- Aged
- Cornea
(pathology)
- Corneal Edema
(diagnosis, drug therapy)
- Corneal Pachymetry
- Double-Blind Method
- Female
- Fuchs' Endothelial Dystrophy
(complications, drug therapy)
- Humans
- Male
- Middle Aged
- Ophthalmic Solutions
(administration & dosage)
- Osmolar Concentration
- Prospective Studies
- Visual Acuity
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