TearScience, Inc., Morrisville, North Carolina, USA.
Curr Eye Res. 2011 Feb;36(2):79-87. doi: 10.3109/02713683.2010.509529.
To evaluate a novel thermodynamic treatment for obstructive meibomian gland dysfunction (MGD).
Fourteen adult subjects (10 females, 4 males, mean age = 54.2 ± 9.6 yr) were recruited in a multi-center, feasibility clinical trial in Durham and Cary, North Carolina and Boston, Massachusetts. Inclusion criteria included: previous diagnosis of moderate to severe dry eye; dry eye symptoms for at least three months prior; daily topical lubricant use; and evidence of meibomian gland (MG) obstruction in the central five glands of both eyes lower eyelids. Exclusion criteria included: history of recent acute or chronic ocular inflammation or infection and lid surface abnormalities affecting lid function. The treatment: the device heats the palpebral surface of upper and lower eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid for 12 min, thereby expressing the MGs during heating. One eye was randomly selected to undergo additional manual heated expression with another treatment device.
The mean MG secretion score, tear break-up time, corneal staining score, number of MGs yielding liquid secretion and symptom scores all improved significantly from baseline to 1 week. This was maintained through the 3-month follow-up. There was no statistically significant difference in any outcome between the automated device treatment only and the additional heated manual expression.
The combination of heat applied to the palpebral surface, while simultaneously expressing MGs during a single 12-minute treatment, was effective, in this feasibility study, in treating obstructive MG dysfunction and dry eye signs and symptoms for the 3-month study period.
评估一种治疗阻塞性睑板腺功能障碍（MGD）的新型热疗方法。
本研究为多中心可行性临床试验，共纳入 14 名成年受试者（10 名女性，4 名男性，平均年龄 54.2 ± 9.6 岁），分别来自北卡罗来纳州达勒姆和卡里以及马萨诸塞州波士顿。纳入标准包括：中重度干眼的既往诊断；干眼症状至少持续 3 个月；每日使用局部润滑剂；双眼下眼睑中央 5 个腺体的睑板腺阻塞的证据。排除标准包括：近期急性或慢性眼部炎症或感染史以及影响眼睑功能的眼睑表面异常。治疗方法：该设备在上、下眼睑的睑结膜表面加热，同时对外侧眼睑施加分级脉动压力 12 分钟，从而在加热过程中排出睑板腺分泌物。一只眼睛随机选择使用另一种治疗设备进行额外的手动加热表达。
与基线相比，MG 分泌评分、泪膜破裂时间、角膜染色评分、产生液体分泌的 MGs 数量以及症状评分均在治疗后 1 周和 3 个月随访时显著改善。这种改善在 3 个月的随访中得以维持。仅使用自动化设备治疗与额外的手动加热表达之间在任何结果上均无统计学差异。
在这项可行性研究中，在单一 12 分钟的治疗中同时对睑结膜表面施加热，并在治疗过程中同步表达睑板腺，对于治疗阻塞性睑板腺功能障碍和干眼的体征和症状是有效的，可在 3 个月的研究期间保持疗效。
