From the Institute of Ocular Microsurgery, Barcelona, Spain (Souki, Güell); CHU Morvan, Brest, France (Cochener); Hôpital Bicêtre, Université Paris Sud, Paris, France (Labetoulle).
J Cataract Refract Surg. 2021 May 1;47(5):570-578. doi: 10.1097/j.jcrs.0000000000000491.
To compare intracameral and topical mydriatics and anesthetics in cataract surgery.
Institute of Ocular Microsurgery, Barcelona, Spain.
Phase IV, open-label, randomized, single-center study.
Patients were randomized in a 1:1 ratio to receive intracameral mydriatic-anesthetic (Mydrane/Fydrane) and anesthetic eyedrops or control (topical eyedrops only). The other treatment was administered for the second cataract surgery. Assessments were performed at presurgery and immediately postsurgery, at 12 to 36 hours postsurgery (day 1), and 7 days postsurgery. The primary endpoint was the change from baseline in corneal/conjunctival surface staining. The secondary endpoints included assessments of epithelial alterations, point-spread function, ocular surface disease index, conjunctival hyperemia, vision breakup time, ocular symptoms/signs, adverse events (AEs), corrected distance visual acuity, intraocular pressure, patient/investigator satisfaction, and procedure time.
A total of 50 patients undergoing sequential cataract surgery in both eyes were included. Baseline assessments were similar in each group. The difference between Fydrane and control groups for the change from baseline at day 1 in corneal and conjunctival surface staining was not statistically significant. For Fydrane, postoperative epithelial alterations were fewer at day 1 (P < .005), folliculopapillary reaction was less frequent (P < .05), some ocular symptoms were less frequent and milder (P < .05), length of procedure was shorter (P < .001), and patient and investigator satisfaction were better (P < .05). There were few AEs in both groups.
Fydrane reduced ocular surface damage by decreasing corneal epithelial and conjunctival toxicity with faster recovery of surface integrity compared with topical eyedrops, improved patient and investigator satisfaction, and reduced procedure time.
比较白内障手术中眼内和局部散瞳剂和麻醉剂的效果。
西班牙巴塞罗那眼显微外科研究所。
四期、开放标签、随机、单中心研究。
患者以 1:1 的比例随机分为两组，分别接受眼内散瞳-麻醉剂（Mydrane/Fydrane）和麻醉眼药水或对照组（仅局部眼药水）治疗。第二次白内障手术时使用另一种治疗方法。评估在术前和术后即刻、术后 12 至 36 小时（第 1 天）和术后 7 天进行。主要终点是角膜/结膜表面染色的基线变化。次要终点包括上皮改变、点扩散函数、眼表疾病指数、结膜充血、视觉破裂时间、眼部症状/体征、不良事件（AE）、矫正远视力、眼压、患者/研究者满意度和手术时间。
共有 50 例双眼接受连续白内障手术的患者入组。每组的基线评估相似。第 1 天 Fydrane 组和对照组在角膜和结膜表面染色的基线变化差异无统计学意义。对于 Fydrane，术后第 1 天上皮改变较少（P <.005），滤泡性乳头反应较少（P <.05），一些眼部症状较少且较轻（P <.05），手术时间较短（P <.001），患者和研究者满意度较高（P <.05）。两组均有少数 AE。
与局部眼药水相比，Fydrane 通过减少角膜上皮和结膜毒性，更快恢复表面完整性，减轻眼表损伤，提高患者和研究者满意度，并缩短手术时间。
