Department of Ophthalmology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No.725 South Wanping Road, Xuhui District, Shanghai, 200032, China.
Department of Ophthalmology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
BMC Ophthalmol. 2024 Aug 26;24(1):376. doi: 10.1186/s12886-024-03642-z.
Warm compresses are the routine treatment for Meibomian gland dysfunction (MGD) in daily life, but in order to achieve satisfactory efficacy, the treatment needs to be sustained over a long time, which can have an impact on the patient compliance. A more convenient warm compresses will help improve the patient compliance. Therefore, the purpose of the study is to investigate the efficacy and safety of the disposable eyelid warming masks for treatment of dry eye disease (DED) due to MGD.
This was a randomized, controlled, non-masked, two-center clinical trial. One hundred and forty-four patients were treated by the masks or the hot towel twice daily for 12 weeks. Patients were evaluated at baseline, 4-week and 12-week visits for subjective symptoms, objective signs and safety assessments, including ocular symptom scores, ocular surface disease index (OSDI), tear break-up time (BUT), corneal fluorescein staining (CFS), Schirmer I test (SIT), meibum quality, meibum expressibility, and adverse events (AEs).
A totle of 134 patients were followed in the study. The mean age of the masks group (14 males and 52 females) and the hot towel group (20 males and 48 females) was 43.7 ± 13.5 years and 39.5 ± 13.9 years, respectively. At 4-week visit, there were significant statistical differences in ocular symptom scores, OSDI and CFS between two groups (P < 0.05). Except for SIT, the treatment group showed a greater improvement in subjective symptoms and objective signs than the control group at 12-week visit. (P < 0.05). In addition, 40 AEs occurred in 27 patients (37.5%) in the treatment group, and 34 AEs occurred in 21 patients (29.17%) in the control group. No serious AEs were reported.
The masks had a good efficacy and safety in the treatment of DED due to MGD, and might offer an attractive treatment option for some patients.
The study was registered at Chinese Clinical Trial Registry (ChiCTR1900025443) on August 26, 2019.
在日常生活中，热敷是治疗睑板腺功能障碍（MGD）的常规治疗方法，但为了达到满意的疗效，治疗需要长期持续，这会影响患者的依从性。更方便的热敷会有助于提高患者的依从性。因此，本研究旨在探讨一次性眼睑加热眼罩治疗睑板腺功能障碍相关性干眼（DED）的疗效和安全性。
这是一项随机、对照、非盲、双中心临床试验。144 例患者每天使用眼罩或热毛巾治疗两次，共 12 周。患者在基线、4 周和 12 周时进行主观症状、客观体征和安全性评估，包括眼表症状评分、眼表疾病指数（OSDI）、泪膜破裂时间（BUT）、角膜荧光素染色（CFS）、泪液分泌试验（SIT）、睑脂质量、睑脂排出量和不良反应（AEs）。
本研究共 134 例患者随访。眼罩组（14 名男性和 52 名女性）和热毛巾组（20 名男性和 48 名女性）的平均年龄分别为 43.7±13.5 岁和 39.5±13.9 岁。在 4 周时，两组间眼表症状评分、OSDI 和 CFS 均有显著统计学差异（P<0.05）。除 SIT 外，治疗组在 12 周时主观症状和客观体征的改善程度均优于对照组（P<0.05）。此外，治疗组 27 例（37.5%）患者共发生 40 例不良反应，对照组 21 例（29.17%）患者共发生 34 例不良反应。均未报告严重不良反应。
一次性眼睑加热眼罩治疗 MGD 相关性 DED 具有良好的疗效和安全性，可能为部分患者提供一种有吸引力的治疗选择。
本研究于 2019 年 8 月 26 日在中国临床试验注册中心（ChiCTR1900025443）注册。
