PMID- 33892048
OWN - NLM
STAT- MEDLINE
DCOM- 20211122
LR  - 20220824
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 128
IP  - 11
DP  - 2021 Nov
TI  - Hyperosmolar Eye Drops for Diurnal Corneal Edema in Fuchs' Endothelial Dystrophy: 
      A Double-Masked, Randomized Controlled Trial.
PG  - 1527-1533
LID - S0161-6420(21)00286-4 [pii]
LID - 10.1016/j.ophtha.2021.04.015 [doi]
AB  - PURPOSE: The Eye Drops for Early Morning-Associated Swelling (EDEMAS) trial 
      assessed the efficacy of hyperosmolar eye drops on corneal edema resolution. 
      DESIGN: Double-masked, randomized controlled trial of hyperosmolar eye drops. 
      PARTICIPANTS: Participants with Fuchs' dystrophy scheduled for Descemet membrane 
      endothelial keratoplasty. 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 mum in the treatment arm and 622 mum in the placebo arm 
      after eye opening, indicating an early morning edema compared with baseline 
      of +21 mum and +24 mum, respectively. Decrease in corneal thickness after 1 hour 
      was -10.5 mum in the treatment arm (95% confidence interval [CI], -12.8 to -8.2) 
      and -11.2 mum (95% CI, -13.6 to -8.9) in the placebo arm (between-arm difference, 
      0.7 mum, 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.
CI  - Copyright (c) 2021 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Zander, Daniel B
AU  - Zander DB
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Bohringer, Daniel
AU  - Bohringer D
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Fritz, Marianne
AU  - Fritz M
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Grewing, Viviane
AU  - Grewing V
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Maier, Philip C
AU  - Maier PC
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Lapp, Thabo
AU  - Lapp T
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Reinhard, Thomas
AU  - Reinhard T
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Wacker, Katrin
AU  - Wacker K
AD  - Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. 
      Electronic address: katrin.wacker@uniklinik-freiburg.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT04140422
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210420
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - 0 (Ophthalmic Solutions)
SB  - IM
CIN - Ophthalmology. 2022 Sep;129(9):e84. PMID: 35623916
MH  - Aged
MH  - Cornea/*pathology
MH  - Corneal Edema/diagnosis/*drug therapy
MH  - Corneal Pachymetry
MH  - Double-Blind Method
MH  - Female
MH  - Fuchs' Endothelial Dystrophy/*complications/drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/*administration & dosage
MH  - Osmolar Concentration
MH  - Prospective Studies
MH  - *Visual Acuity
OTO - NOTNLM
OT  - Adverse events
OT  - Corneal edema
OT  - Efficacy
OT  - Fuchs' dystrophy
OT  - Hyperosmolar eye drops
OT  - Investigator-initiated randomized controlled trial
OT  - Placebo
EDAT- 2021/04/24 06:00
MHDA- 2021/11/23 06:00
CRDT- 2021/04/23 20:13
PHST- 2021/01/17 00:00 [received]
PHST- 2021/04/05 00:00 [revised]
PHST- 2021/04/08 00:00 [accepted]
PHST- 2021/04/24 06:00 [pubmed]
PHST- 2021/11/23 06:00 [medline]
PHST- 2021/04/23 20:13 [entrez]
AID - S0161-6420(21)00286-4 [pii]
AID - 10.1016/j.ophtha.2021.04.015 [doi]
PST - ppublish
SO  - Ophthalmology. 2021 Nov;128(11):1527-1533. doi: 10.1016/j.ophtha.2021.04.015. 
      Epub 2021 Apr 20.