PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: Ethics approval number: IRB(2023)K019.01. The findings will be shared regardless of the effect\'s direction.
BACKGROUND: NCT05923528.
METHODS: 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.
BACKGROUND: Ethics approval number: IRB(2023)K019.01. The findings will be shared regardless of the effect\'s direction.
BACKGROUND: NCT05923528.
摘要：
背景：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（EDE）的主要原因之一，导致过度蒸发（所谓的高蒸发干眼）。本研究方案将被设计为评估和比较强脉冲光（IPL）的影响，加热眼罩（HEM），矢量热脉动系统（VTPS）和眼睑按摩装置（EMD），用于改善EDE的体征和症状。
方法：将患有EDE的患者随机分为IPL，HEM,VTPS和EMD组并将随访6周。主要结果测量将是非侵入性泪液破裂时间(NITBUT)。次要结果措施将包括，TFLL得分,睑板腺的质量和表达性从基线结膜角膜染色的荧光素和lissamine变化，撕裂半月板高度，结膜充血（红肿评分）和眼表疾病指数问卷。此外,不良事件将被监测和记录.
背景：道德批准号：IRB（2023）K019.01。无论影响方向如何，调查结果都将被分享。
背景：NCT05923528。
方法：将患有EDE的患者随机分为IPL，HEM,VTPS和EMD组并将随访6周。主要结果测量将是非侵入性泪液破裂时间(NITBUT)。次要结果措施将包括，TFLL得分,睑板腺的质量和表达性从基线结膜角膜染色的荧光素和lissamine变化，撕裂半月板高度，结膜充血（红肿评分）和眼表疾病指数问卷。此外,不良事件将被监测和记录.
背景：道德批准号：IRB（2023）K019.01。无论影响方向如何，调查结果都将被分享。
背景：NCT05923528。
