Purpose

To assess long-term cumulative treatment effects of intense pulsed light (IPL) therapy in meibomian gland dysfunction (MGD).

Methods

Eighty-seven symptomatic participants (58 female, mean ± SD age, 53 ± 16 years) with clinical signs of MGD were enrolled in a prospective, double-masked, parallel-group, randomised, placebo-controlled trial. Participants were randomised to receive either four or five homogeneously sequenced light pulses or placebo treatment to both eyes, (E-Eye Intense Regulated Pulsed Light, E-Swin, France). Visual acuity, dry eye symptomology, tear film parameters, and ocular surface characteristics were assessed immediately before treatment on days 0, 15, 45, 75, and four weeks after treatment course completion on day 105. Inflammatory and goblet cell function marker expression, and eyelid swab microbiology cultures were evaluated at baseline and day 105.

Results

Significant decreases in OSDI, SPEED, and SANDE symptomology scores, and meibomian gland capping, accompanied by increased tear film lipid layer thickness, and inhibited Corynebacterium macginleyi growth were observed in both treatment groups (all p < 0.05). Sustained clinical improvements occurred in both treatment groups from day 75, although significant changes from day 45, in lipid layer quality, meibomian gland capping, OSDI and SANDE symptomology, were limited to the five-flash group (all p < 0.05).

Conclusions

IPL therapy effected significant improvements in dry eye symptomology, tear film lipid layer thickness, and meibomian gland capping in MGD patients. Five-flash IPL treatment showed superior clinical efficacy to four-flash, and an initial course of at least four treatments is suggested to allow for establishment of sustained cumulative therapeutic benefits prior to evaluation of overall treatment efficacy.

Trial registration number

ACTRN12616000667415.

中文翻译：

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大剂量脉冲光疗法治疗睑板腺功能障碍的累积治疗效果的随机双盲安慰剂对照试验。

目的

评估强脉冲光（IPL）治疗睑板腺功能障碍（MGD）的长期累积治疗效果。

方法

一项有MGD临床体征的八十七名有症状的参与者（58名女性，平均±SD年龄，53±16岁）参加了一项前瞻性，双盲，平行分组，随机，安慰剂对照试验。参与者被随机分配接受两只或四只或五只均一序列的光脉冲或安慰剂治疗（E-Eye Intense Regulated Pulsed Light，E-Swin，法国）。在治疗前第0、15、45、75和第105天治疗结束后第4天立即评估治疗前的视敏度，干眼症状，泪膜参数和眼表特征。炎症和杯状细胞功能标记物的表达，以及在基线和第105天评估了眼睑拭子微生物学培养物。

结果

在两个治疗组中均观察到OSDI，SPEED和SANDE症状评分显着降低，睑板腺结膜，伴有泪膜脂质层厚度增加，以及抑制了棒状杆菌生长（所有p <0.05）。从第75天起，两个治疗组均出现了持续的临床改善，尽管从第45天起，脂质层质量，睑板腺封盖，OSDI和SANDE症状方面的显着变化仅限于五闪组（所有p <0.05）。

结论

IPL治疗对MGD患者的干眼症状，泪膜脂质层厚度和睑板腺覆盖显着改善。五次闪光IPL治疗显示出优于四次闪光的临床疗效，并且建议至少进行四次治疗的初始过程可以在评估总体治疗效果之前建立持续的累积治疗益处。

试用注册号

ACTRN12616000667415。