Complete Eye Care of Medina, Medina, Minnesota.
ProCare Vision Center, Granville, Ohio.
Optom Vis Sci. 2022 Apr 1;99(4):323-332. doi: 10.1097/OPX.0000000000001892.
Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months.
This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye.
In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of <10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of >16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes.
A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference, >-5), NITBUT (>-2.5 seconds), and IDEEL-SB score (95% upper confidence limit, <12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported.
The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.
鉴于睑板腺功能障碍患者在蒸发性干眼症中的重要性、其慢性和进行性、有限的有前景的治疗选择以及新的治疗技术的重要性。这项随机临床试验评估了 SYSTANE iLux 与 LipiFlow 在治疗睑板腺功能障碍中的非劣效性，随访时间为 12 个月。
本研究旨在证明在患有蒸发性干眼症的睑板腺功能障碍患者中，单次治疗 12 个月后，SYSTANE iLux 与 LipiFlow 相比具有非劣效性。
在这项前瞻性、随机、多中心、评估者盲法、平行组试验中，纳入了下眼睑睑板腺评分（MGS）≤12、非侵入性泪膜破裂时间（NITBUT；第一次破裂）<10 秒和干眼对日常生活影响-症状困扰（IDEEL-SB）模块评分>16 的睑板腺功能障碍伴蒸发性干眼症患者（N=236；年龄≥18 岁），并将其随机（1:1）分为接受 SYSTANE iLux（n=119）或 LipiFlow（n=117）治疗。患者共接受了 8 次访视，包括筛查、治疗和治疗后 2 周以及 1、3、6、9 和 12 个月/退出时的随访，以评估 MGS、NITBUT、IDEEL-SB 模块评分从基线的变化以及安全性结局。
共有 227 名患者完成了这项研究（平均年龄±标准差，57.3±13.8 岁）。在 12 个月时，iLux 和 LipiFlow 组的 MGS 从基线的最小二乘均值变化相似（17.4±1.97 与 17.8±1.98）。SYSTANE iLux 在 MGS（95%置信下限最小二乘均值差>−5）、NITBUT（>−2.5 秒）和 IDEEL-SB 评分（95%置信上限<12）的从基线变化方面的非劣效性与 LipiFlow 相比在所有治疗后访视时均得到了证实。在试验过程中没有报告其他严重的眼部或器械相关不良事件。
在 12 个月的随访中，SYSTANE iLux 的治疗结果与 LipiFlow 相比在干眼症相关的睑板腺功能障碍患者中具有非劣效性。
