Ineye Hospital of Chengdu University of Traditional Chinese Medicine, Eye School of Chengdu University of Traditional Chinese Medicine, Chengdu, 610084, China.
Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, 300384, China.
Int Ophthalmol. 2023 Apr;43(4):1175-1184. doi: 10.1007/s10792-022-02516-x. Epub 2022 Sep 16.
Evaluate the efficacy and safety of LipiFlow thermal pulsation treatment system compared with lid massage combined warm compress in Chinese patients with meibomian gland dysfunction (MGD).
Patients (n = 100 eyes, 50 subjects) diagnosed with MGD were recruited for this prospective, randomized, 3-month clinical trial. In Lipiflow group, patients (n = 50 eyes) received a single LipiFlow thermal pulsation system treatment. In warm compress group, patients (n = 50 eyes) underwent warm compress daily for two weeks after an initial manual lid massage. Patients' symptoms were evaluated using Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire. Safety parameters included best-corrected visual acuity (BCVA), intraocular pressure (IOP) and objective parameters including meibomian glands yielding lipid secretion (MGYLS) number, meibomian glands secretion (MGS) score, lipid layer thickness (LLT), tear-film breakup time (TBUT), corneal fluorescein staining (CFS) were measured and presented from baseline and to 3 months post-treatment.
Baseline parameters in both groups were comparable (p > 0.05). SPEED score and TBUT improved in two groups from baseline to 3 months. MGYLS number, MGS score, LLT improved in LipiFlow group and these improvements were maintained with no significant regression at 3 months. CFS showed significant improvement in warm compress group at 1 month compared with LipiFlow group. Moreover, the correlation analysis indicated LLT was positively correlated with TBUT, MGS score, and MGYLS number.
A single 12-min LipiFlow treatment is an effective therapy for MGD patients and can achieve improvements in symptoms alleviation and meibomian gland lipid secretion function lasting for at least 3 months.
评估 LipiFlow 热脉动治疗系统与 lid massage 联合热敷治疗中国人群中睑板腺功能障碍（MGD）的疗效和安全性。
本前瞻性、随机、3 个月临床试验纳入了 MGD 患者（n=100 眼，50 例）。在 Lipiflow 组中，患者（n=50 眼）接受单次 LipiFlow 热脉动系统治疗。在热敷组中，患者（n=50 眼）在初始 lid massage 后每日接受热敷治疗两周。使用 Standard Patient Evaluation for Eye Dryness（SPEED）问卷评估患者症状。安全性参数包括最佳矫正视力（BCVA）、眼压（IOP）和客观参数，包括睑板腺产油能力（MGYLS）数量、睑板腺分泌（MGS）评分、脂质层厚度（LLT）、泪膜破裂时间（TBUT）、角膜荧光素染色（CFS），并从基线和治疗后 3 个月进行测量和呈现。
两组的基线参数相当（p>0.05）。SPEED 评分和 TBUT 在两组中均从基线到 3 个月有所改善。MGYLS 数量、MGS 评分和 LLT 在 Lipiflow 组中得到改善，这些改善在 3 个月时保持稳定，没有明显的回退。与 Lipiflow 组相比，热敷组在 1 个月时 CFS 显著改善。此外，相关性分析表明 LLT 与 TBUT、MGS 评分和 MGYLS 数量呈正相关。
单次 12 分钟的 LipiFlow 治疗是 MGD 患者的有效治疗方法，可以实现症状缓解和睑板腺脂质分泌功能的改善，至少持续 3 个月。
