From the Cornea Research Foundation of America, Indianapolis, Indiana, USA (M.O.P.); Price Vision Group, Indianapolis, Indiana, USA (F.W.P.)..
From the Cornea Research Foundation of America, Indianapolis, Indiana, USA (M.O.P.); Price Vision Group, Indianapolis, Indiana, USA (F.W.P.).
Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15.
To evaluate off-label use of netarsudil 0.02% for treatment of corneal edema associated with Fuchs dystrophy.
Prospective, randomized clinical trial.
Twenty-nine subjects with symptomatic Fuchs dystrophy were enrolled and randomized to use netarsudil or placebo eye drops once daily for 3 months. The primary outcomes were the change in central corneal thickness between baseline and 1 month and between baseline and 3 months. Secondary outcomes included change in scotopic corrected distance visual acuity (CDVA) at 3 months and change in scores on a visual disability questionnaire validated for use with Fuchs dystrophy.
Compared with use of placebo, use of netarsudil produced significant reduction in central corneal thickness at 1 month (mean difference, -20 µm; 95% confidence interval, -32 to -9 µm) and 3 months (mean difference, -26 µm; 95% confidence interval, -39 to -12 µm) and significant improvement in scotopic CDVA at 3 months (mean difference +1.6 lines; 95% confidence interval, 0.2-3.0 lines). Scores on the visual disability questionnaire did not change significantly in either arm or differ significantly between arms. One subject assigned to netarsudil had baseline epithelial bullae and withdrew from the study because of disabling glare.
Use of netarsudil was associated with reduction of corneal edema and improvement in scotopic CDVA in Fuchs dystrophy patients. Further study is needed to more fully assess patient satisfaction and visual acuity under various lighting conditions and to compare use of netarsudil with other treatment options such as endothelial keratoplasty.
评估 netarsudil 0.02% 用于治疗 Fuchs 营养不良相关角膜水肿的标签外使用。
前瞻性、随机临床试验。
29 例有症状的 Fuchs 营养不良患者入组并随机分为 netarsudil 或安慰剂滴眼液，每天一次，治疗 3 个月。主要结局是从基线到 1 个月和从基线到 3 个月的中央角膜厚度变化。次要结局包括 3 个月时暗视力矫正距离视力（CDVA）的变化和用于 Fuchs 营养不良的视觉障碍问卷评分的变化。
与安慰剂相比，使用 netarsudil 在 1 个月（平均差异，-20µm；95%置信区间，-32 至-9µm）和 3 个月（平均差异，-26µm；95%置信区间，-39 至-12µm）时中央角膜厚度明显降低，3 个月时暗视力 CDVA 明显改善（平均差异+1.6 行；95%置信区间，0.2-3.0 行）。视觉障碍问卷评分在两组中均无显著变化，两组间差异也无统计学意义。一名被分配到 netarsudil 的患者有基线上皮水疱，因眩光而退出研究。
在 Fuchs 营养不良患者中，使用 netarsudil 可减轻角膜水肿并提高暗视力 CDVA。需要进一步研究以更全面地评估各种光照条件下的患者满意度和视力，并比较 netarsudil 与内皮角膜移植等其他治疗选择的使用。
