Sadri Ehsan, Verachtert Anthony, Parkhurst Gregory D, Echegoyen Julio, Klein Ifat, Agmon Yael G, Berdy Gregg J
Visionary Eye Institute, Newport Beach CA, USA.
Moyes Eye Center, PC, Kansas City, MO, USA.
J Cataract Refract Surg. 2024 Dec 16;51(4):274-81. doi: 10.1097/j.jcrs.0000000000001602.
To evaluate the safety and effectiveness of thermo-mechanical action (Tixel C, Novoxel) compared with thermal pulsation (LipiFlow, Johnson & Johnson) in meibomian gland dysfunction (MGD).
Private clinics and University clinic, USA.
Prospective, randomized (1:1), evaluator-masked, multicenter study.
Subjects with Ocular Surface Disease Index (OSDI) between 23 and 79, fluorescein tear break-up time (TBUT) <10 s and Meibomian Gland Score (MGS) ≤12 in each eye received bilateral thermo-mechanical action (TMA) or thermal pulsation (TP). The treatment consisted of three sessions, two weeks apart, for TMA and one session for TP. TBUT, OSDI, MGS, and corneal and conjunctival staining (CCS) were assessed at baseline and at Weeks 4 and 12 post-last treatment session. The primary effectiveness endpoint was change in TBUT at Week 4.
Among the 106 treated subjects (N=53 per group), TBUT improved significantly (p<0.001) by 3.0±3.2 and 3.1±4.3 seconds after TMA and 2.7±2.7 and 3.3±3.6 seconds after TP, at Week 4 and Week 12, respectively. The change in TBUT for TMA was non-inferior to TP (linear mixed-effects model, p<0.001). OSDI, MGS and CCS significantly improved from baseline (p<0.001), with no significant between-group differences (p>0.05). OSDI improved by 26.4±21.1 and 28.6±22.4 after TMA and 18.8±21.0 and 21.9±18.5 after TP, at Week 4 and Week 12, respectively. No device-related adverse event occurred in either group.
TMA safely and effectively improved clinical signs and symptoms of evaporative dry eye disease associated with MGD over a 12-week period, comparable to TP.
评估热机械作用（Tixel C，Novoxel）与热脉动（LipiFlow，强生公司）相比，在睑板腺功能障碍（MGD）中的安全性和有效性。
美国的私人诊所和大学诊所。
前瞻性、随机（1:1）、评估者盲法、多中心研究。
眼表疾病指数（OSDI）在23至79之间、荧光素泪膜破裂时间（TBUT）<10秒且每只眼睛的睑板腺评分（MGS）≤12的受试者接受双侧热机械作用（TMA）或热脉动（TP）。治疗包括三个疗程，TMA疗程间隔两周，TP为一个疗程。在基线以及最后一次治疗疗程后的第4周和第12周评估TBUT、OSDI、MGS以及角膜和结膜染色（CCS）。主要有效性终点是第4周时TBUT的变化。
在106名接受治疗的受试者中（每组N = 53），TMA组在第4周和第12周时，TBUT分别显著改善（p < 0.001），改善了3.0±3.2秒和3.1±4.3秒；TP组分别改善了2.7±2.7秒和3.3±3.6秒。TMA组的TBUT变化不劣于TP组（线性混合效应模型，p < 0.001）。OSDI、MGS和CCS较基线均显著改善（p < 0.001），组间无显著差异（p > 0.05）。TMA组在第4周和第12周时，OSDI分别改善了26.4±21.1和28.6±22.4；TP组分别改善了18.8±21.0和21.9±18.5。两组均未发生与器械相关的不良事件。
在12周的时间里，TMA安全有效地改善了与MGD相关的蒸发型干眼疾病的临床体征和症状，与TP相当。
