使用一种新型设备测量伴有和不伴有干燥综合征的干眼患者的泪液脂质层厚度与眼部舒适度。

Tear lipid layer thickness and ocular comfort with a novel device in dry eye patients with and without Sjögren's syndrome.

作者信息

Spiteri A, Mitra M, Menon G, Casini A, Adams D, Ricketts C, Hickling P, Fuller E T, Fuller J R

机构信息

Department of Ophthalmology, Royal Eye Infirmary, Plymouth, United Kingdom.

出版信息

J Fr Ophtalmol. 2007 Apr;30(4):357-64. doi: 10.1016/s0181-5512(07)89605-7.

DOI:10.1016/s0181-5512(07)89605-7

PMID:17486027

Abstract

BACKGROUND

To measure changes in tear-film lipid-layer thickness (LLT) and symptoms in patients with dry eye symptoms with and without Sjögren's syndrome after using a novel device. The device is designed to promote release of meibomian sebum into the tear film by delivering latent heat to the eyelids.

STUDY DESIGN

Two prospective, controlled, randomised, observer-masked, single-intervention studies.

METHODS

Two independent studies were conducted in a major university hospital in the South West of England. The first study involved 24 patients with dry eye symptoms without Sjögren's [the PDE study] and the second study involved 31 patients with dry eye symptoms and Sjögren's syndrome (the SS study). The PDE study was randomised into two groups. Group I (12 patients) underwent 10 min of treatment with the activated device and Group II (12 patients) had no treatment. The SS study was similarly randomised into Group I (17 patients) and Group II (14 patients). The LLT and subjective alterations in ocular comfort of each subject were assessed prior and immediately after 5 and 30 min subsequent to the 10-min period. In the SS study, a further assessment was carried out at 60 min.

RESULTS

In the PDE study, treated patients exhibited a bilateral increase of LLT at 5 min (right eyes, 1.2 levels, p<0.0005; left eyes, 1.0 levels, p<0.0005, Mann-Whitney) and at 30 min (right eyes, 0.7 levels, p<0.005; left eyes, 0.6 levels, p<0.005). Mean symptom scores improved in the treated group compared with the control group at 5 min (treatment group, +2.0; control group, +0.2; p<0.05) and 30 min (treatment group, +2.8; control group, +0.4; p<0.015). In the SS study, treated patients exhibited a bilateral increase of LLT, 5 min (right eyes, 0.5 levels, p<0.009; left eyes, 0.5 levels, p<0.005, Monte Carlo 2-tailed), 30 min (right eyes, 0.5 levels, p<0.007; left eyes 0.5 levels, p<0.002) and 60 min (right eyes, 0.3 levels, p<0.1; left eyes, 0.3 levels, p<0.05). There was no change in any of the control patients in any of the assessments. With regard to symptom scores, the mean change at 5 min measured +0.8 in the treatment group and remained relatively unchanged at +0.1 in the control group (p<0.1). At 30 min, this change measured +1.3 in the treatment group and +0.1 in the control group (p<0.03) and at 60 min, the change measured +1.5 in the treatment group and remained at +0.1 in the control group (p<0.02).

CONCLUSION

Meibomian therapy with this novel device increases LLT and ocular comfort in patients with dry eye symptoms with and without Sjögren's syndrome.

摘要

背景

使用一种新型设备，测量有无干燥综合征的干眼症患者泪膜脂质层厚度（LLT）的变化及症状。该设备旨在通过向眼睑传递潜热，促进睑板腺皮脂释放到泪膜中。

研究设计

两项前瞻性、对照、随机、观察者盲法、单干预研究。

方法

在英格兰西南部的一家大型大学医院进行了两项独立研究。第一项研究纳入了24名无干燥综合征的干眼症患者（PDE研究），第二项研究纳入了31名有干燥综合征的干眼症患者（SS研究）。PDE研究随机分为两组。第一组（12名患者）使用激活的设备进行10分钟治疗，第二组（12名患者）不接受治疗。SS研究同样随机分为第一组（17名患者）和第二组（14名患者）。在10分钟治疗期之前以及之后5分钟和30分钟即刻，评估每个受试者的LLT和眼部舒适度的主观变化。在SS研究中，60分钟时进行了进一步评估。

结果

在PDE研究中，治疗组患者在5分钟时双侧LLT增加（右眼，1.2级，p<0.0005；左眼，1.0级，p<0.0005，曼-惠特尼检验），30分钟时也增加（右眼，0.7级，p<0.005；左眼，0.6级，p<0.005）。与对照组相比，治疗组在5分钟时（治疗组，+2.0；对照组，+0.2；p<0.05）和30分钟时（治疗组，+2.8；对照组，+0.4；p<0.015）平均症状评分改善。在SS研究中，治疗组患者在5分钟时双侧LLT增加（右眼，0.5级，p<0.009；左眼，0.5级，p<0.005，蒙特卡洛双尾检验），30分钟时增加（右眼，0.5级，p<0.007；左眼，0.5级，p<0.002），60分钟时增加（右眼，0.3级，p<0.1；左眼，0.3级，p<0.05）。在任何评估中，对照组患者均无变化。关于症状评分，治疗组在5分钟时平均变化为+0.8，对照组相对无变化，为+0.1（p<0.1）。在30分钟时，治疗组变化为+1.3，对照组为+0.1（p<0.03），在60分钟时，治疗组变化为+1.5，对照组仍为+0.1（p<0.02）。