He Eye Specialist Hospital, Shenyang, Liaoning, China.
He University, Shenyang, Liaoning, China.
BMJ Open. 2024 Feb 26;14(2):e078727. doi: 10.1136/bmjopen-2023-078727.
The lipid layer of the tear film is critical to maintaining the integrity of the tear film and absence in the tear film lipid layer (TFLL) is one of the main causes of evaporative dry eye (EDE) in dry eye disease patients, resulting in excessive evaporation (so-called hyperevaporative dry eye). This study protocol will be designed to assess and compare the effects of intense pulsed light (IPL), heated eye mask (HEM), vectored thermal pulsation system (VTPS) and eyelid massage device (EMD) for improving signs and symptoms of EDE.
Patients with EDE will be randomly divided into IPL, HEM, VTPS and EMD groups and will be followed up for 6 weeks. The primary outcome measure will be non-invasive tear breakup time (NITBUT). The secondary outcome measures will include, TFLL score, meibomian gland quality and expressibility change from baseline conjunctivocorneal staining with fluorescein and lissamine, tear meniscus height, conjunctival hyperaemia (redness score) and ocular surface disease index questionnaire. Additionally, adverse events will be monitored and documented.
Ethics approval number: IRB(2023)K019.01. The findings will be shared regardless of the effect's direction.
NCT05923528.
泪膜的脂质层对于维持泪膜的完整性至关重要，而泪膜脂质层（TFLL）的缺失是干眼症患者蒸发性干眼症（EDE）的主要原因之一，导致过度蒸发（即所谓的高蒸发性干眼症）。本研究方案旨在评估和比较强脉冲光（IPL）、加热眼罩（HEM）、向量热脉冲系统（VTPS）和眼睑按摩器（EMD）对改善 EDE 的体征和症状的效果。
EDE 患者将被随机分为 IPL、HEM、VTPS 和 EMD 组，并随访 6 周。主要结局指标为非侵入性泪膜破裂时间（NITBUT）。次要结局指标包括 TFLL 评分、从基线开始的荧光素和丽丝胺结膜角膜染色的睑板腺质量和可表达性变化、泪膜新月高度、结膜充血（红肿评分）和眼表面疾病指数问卷。此外，将监测和记录不良事件。
伦理批准编号：IRB（2023）K019.01。无论效果方向如何，研究结果都将共享。
NCT05923528。
