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Katrin Wacker, Daniel Zander, Daniel Böhringer, Marianne Fritz, Viviane Grewing, Thabo Lapp, Philip Maier, Thomas Reinhard; Hyperosmolar eye drops for diurnal corneal edema in Fuchs endothelial dystrophy: a double-blind randomized-controlled trial. Invest. Ophthalmol. Vis. Sci. 2021;62(8):815.
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To assess the efficacy of hyperosmolar eye drops on corneal edema resolution.
The double-blind randomized-controlled Eye Drops for Early Morning-Associated Swelling (EDEMAS) trial included participants without ocular comorbidities other than Fuchs’ dystrophy scheduled for Descemet membrane endothelial keratoplasty (DMEK). One eye was randomized to hyperosmolar eye drops (treatment), while the fellow eye was randomized to artificial tears (placebo). After a baseline exam in the afternoon, participants’ corneas were examined using Scheimpflug tomography after eye opening in the hospital in the morning. Imaging was repeated every 30 minutes up to four hours. Participants received eye drops twice. Primary endpoint was decrease in central corneal thickness one hour after eye opening. Secondary endpoints were corneal thickness, subjective visual function, glare, visual acuity, and adverse events over the duration of the study.
68 participants received the allocated intervention (59 eyes treatment, 55 eyes placebo). 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 to baseline of +21 µm and +24 µm, respectively. Decrease in corneal thickness after one hour was -10.5 µm in the treatment arm (95% 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 effect of hyperosmolar eye drops on early-morning associated corneal edema. Corneal thickness decrease, and improvement of visual acuity and glare over the entire course of the study duration were not different between treatment and placebo. Subjective visual function tended to be worse in the treatment 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 to 62).
In the double-blind randomized-controlled EDEMAS trial, resolution of early-morning associated edema was not accelerated by hyperosmolar eye drops, which frequently caused adverse events. These results are not compatible with a clinically meaningful effect of hyperosmolar eye drops in Fuchs’ dystrophy and do not support their routine use.
This is a 2021 ARVO Annual Meeting abstract.
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