Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.

Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.
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DOI:
10.1136/bjophthalmol-2014-305220
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发表时间:
2014-12
期刊:
The British journal of ophthalmology
影响因子:
--
通讯作者:
Wolffsohn JS
Wolffsohn JS
中科院分区:
其他
文献类型:
--
作者:
Bilkhu PS;Naroo SA;Wolffsohn JS

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旨在研究 MGDRx EyeBag(The Eyebag Company,哈利法克斯,英国)眼睑加热装置的功效和安全性。 25 名确诊为睑板腺功能障碍 (MGD) 相关蒸发性干眼症的患者被纳入一项随机、单盲、对侧临床试验。测试眼睛接受加热装置;使用非加热设备控制眼睛,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、非侵入性破裂时间、脂质层厚度、渗透压、睑板腺脱落和功能)和安全性(视力、角膜地形图、结膜充血和染色)测量。随后的患者设备使用情况和眼部舒适度在 6 个月时确定。对于所有测量,测试眼和对照眼之间的基线差异均不具有统计学显着性 (p>0.05)。 2 周后,测试眼的所有功效测量均出现统计学上显着的改善(p<0.05)。视力和角膜地形图不受影响(p>0.05)。所有患者在 6 个月后都保持了较高的眼部舒适度 (p<0.05),尽管每月继续使用 1-8 次的患者获益更大 (p<0.001)。 MGDRx EyeBag 是一种安全有效的治疗 MGD 相关蒸发性干眼症的设备。在偶尔再治疗的帮助下,主观获益至少持续 6 个月。 NCT01870180。
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.
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