Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Eye Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Ophthalmology. 2021 Nov;128(11):1527-1533. doi: 10.1016/j.ophtha.2021.04.015. Epub 2021 Apr 20.
The Eye Drops for Early Morning-Associated Swelling (EDEMAS) trial assessed the efficacy of hyperosmolar eye drops on corneal edema resolution.
Double-masked, randomized controlled trial of hyperosmolar eye drops.
Participants with Fuchs' dystrophy scheduled for Descemet membrane endothelial keratoplasty.
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.
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).
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).
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.
EDEMAS 试验评估了高渗滴眼液对角膜水肿消退的疗效。
双盲、随机对照的高渗滴眼液试验。
计划行 Descemet 膜内皮角膜移植术的 Fuchs 营养不良患者。
一眼随机分配至高渗滴眼液（治疗组）；另一眼随机分配至人工泪液（安慰剂组）。下午进行基线检查后，在早晨睁眼时使用 Scheimpflug 断层扫描检查角膜。参与者接受两次滴眼。每隔 30 分钟至 4 小时重复成像。
睁眼后 1 小时中央角膜厚度的变化（主要终点）、角膜厚度、主观视觉功能、眩光、视力和不良事件（AE）（次要终点）。
共 68 名参与者接受了分配的干预（59 只眼接受治疗；55 只眼接受安慰剂）。所有眼睛均有基质水肿；无上皮水肿。睁眼后，治疗组角膜厚度为 626μm，安慰剂组为 622μm，与基线相比分别增加了+21μm和+24μm，提示存在清晨水肿。治疗后 1 小时，角膜厚度下降了-10.5μm（95%置信区间[CI]，-12.8 至-8.2），安慰剂组下降了-11.2μm（95% CI，-13.6 至-8.9）（组间差异，0.7μm；95%CI，-2.0 至 3.5；P=0.59），表明高渗滴眼液对清晨角膜水肿无明显临床作用。结果与整个研究过程中角膜厚度、视力和眩光的相关治疗效果不一致。治疗组主观视觉功能的改善速度比安慰剂组慢。治疗组（30 只眼）比安慰剂组（1 只眼）更常见眼部滴药后烧灼感等不良反应（风险差异，49 个百分点；95%CI，36-62）。
在这项双盲、随机对照试验中，高渗滴眼液并未加速清晨基质水肿的消退，反而更常引起不良反应。这些结果与高渗滴眼液的临床相关作用不一致，不支持其常规使用。
