Holland Edward J, Loh Jennifer, Bloomenstein Marc, Thompson Vance, Wirta David, Dhamdhere Kavita
Cincinnati Eye Institute, Edgewood, KY, USA.
Loh Ophthalmology Associates, Miami, FL, USA.
Clin Ophthalmol. 2022 Aug 30;16:2861-2871. doi: 10.2147/OPTH.S368319. eCollection 2022.
To compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).
In this multicenter, masked, randomized-controlled trial, 235 subjects received a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for 1-month post-treatment. DED symptoms were assessed using the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), and Eye Dryness (ED) questionnaires at baseline and at 1 month. Post-hoc subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS).
TearCare system significantly improved total OSDI, SANDE, and ED scores from baseline ( < 0.0001) at 1-month follow-up. Subjects with more severe disease (MGSS <7) achieved statistically greater reduction with TearCare compared to LipiFlow in total OSDI score (30.4 ± 2.53 and 21.9 ± 2.37, respectively, = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, = 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, = 0.0455).
TearCare provides significant DED symptom relief at 1 month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments. In subjects with more severe gland dysfunction, TearCare performed significantly better than LipiFlow in improving quality of vision and overall DED symptom frequency determined by OSDI and SANDE.
NCT03857919.
比较TearCare和Lipiflow系统减轻与睑板腺功能障碍（MGD）相关的干眼疾病（DED）症状的能力。
在这项多中心、双盲、随机对照试验中，235名受试者接受了单次TearCare治疗（n = 115）或单次LipiFlow治疗（n = 120），并在治疗后随访1个月。在基线和1个月时，使用眼表疾病指数（OSDI）、干眼症状评估（SANDE）和眼干（ED）问卷对DED症状进行评估。根据基线睑板腺分泌评分（MGSS）对腺体阻塞较轻和较重的受试者进行事后亚组分析。
在1个月的随访中，TearCare系统显著改善了总OSDI、SANDE和ED评分，与基线相比差异有统计学意义（<0.0001）。疾病较严重（MGSS<7）的受试者中，与LipiFlow相比，TearCare在总OSDI评分（分别为30.4±2.53和21.9±2.37，P = 0.0160）、OSDI B部分视力质量评分（分别为5.1±0.48和3.6±0.45，P = 0.0206）以及SANDE频率评分（分别为51.9±3.70和41.5±3.45，P = 0.0455）方面的降低在统计学上更显著。
单次治疗后1个月，TearCare能显著缓解DED症状。在OSDI、SANDE和ED评估中结果一致。在腺体功能障碍较严重的受试者中，TearCare在改善视力质量以及由OSDI和SANDE确定的总体DED症状频率方面明显优于LipiFlow。
NCT03857919。
