Bilkhu Paramdeep Singh, Naroo Shehzad Anjam, Wolffsohn James Stuart
Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, West Midlands, UK.
Br J Ophthalmol. 2014 Dec;98(12):1707-11. doi: 10.1136/bjophthalmol-2014-305220. Epub 2014 Jul 4.
BACKGROUND/AIMS: To investigate the efficacy and safety of the MGDRx EyeBag (The Eyebag Company, Halifax, UK) eyelid warming device.
Twenty-five patients with confirmed meibomian gland dysfunction (MGD)-related evaporative dry eye were enrolled into a randomised, single masked, contralateral clinical trial. Test eyes received a heated device; control eyes a non-heated device for 5 min twice a day for 2 weeks. Efficacy (ocular symptomology, non-invasive break-up time, lipid layer thickness, osmolarity, meibomian gland dropout and function) and safety (visual acuity, corneal topography, conjunctival hyperaemia and staining) measurements were taken at baseline and follow-up. Subsequent patient device usage and ocular comfort was ascertained at 6 months.
Differences between test and control eyes at baseline were not statistically significant for all measurements (p>0.05). After 2 weeks, statistically significant improvements occurred in all efficacy measurements in test eyes (p<0.05). Visual acuity and corneal topography were unaffected (p>0.05). All patients maintained higher ocular comfort after 6 months (p<0.05), although the benefit was greater in those who continued usage 1-8 times a month (p<0.001).
The MGDRx EyeBag is a safe and effective device for the treatment of MGD-related evaporative dry eye. Subjective benefit lasts at least 6 months, aided by occasional retreatment.
NCT01870180.
背景/目的：研究MGDRx眼袋（英国哈利法克斯的The Eyebag Company公司生产）眼睑温热装置的疗效和安全性。
25例确诊为睑板腺功能障碍（MGD）相关蒸发型干眼的患者纳入一项随机、单盲、对侧临床试验。试验眼使用加热装置；对照眼使用非加热装置，每天两次，每次5分钟，持续2周。在基线和随访时进行疗效（眼部症状、非侵入性泪膜破裂时间、脂质层厚度、渗透压、睑板腺缺失和功能）和安全性（视力、角膜地形图、结膜充血和染色）测量。在6个月时确定患者随后使用装置的情况和眼部舒适度。
所有测量指标在基线时试验眼和对照眼之间的差异均无统计学意义（p>0.05）。2周后，试验眼所有疗效测量指标均有统计学意义的改善（p<0.05）。视力和角膜地形图未受影响（p>0.05）。6个月后所有患者的眼部舒适度均较高（p<0.05），尽管每月继续使用1 - 8次的患者受益更大（p<0.001）。
MGDRx眼袋是治疗MGD相关蒸发型干眼的一种安全有效的装置。主观获益至少持续6个月，偶尔再次治疗会有帮助。
NCT01870180。
