AI Article Synopsis
- * Patients with EDE will be randomly assigned to one of the four treatment groups and monitored over six weeks, with primary focus on non-invasive tear breakup time (NITBUT) as the main outcome measure.
- * The study also prioritizes ethical standards, with findings to be published regardless of whether the results are positive or negative, and it is registered under trial number NCT05923528.
Article Abstract
Introduction: 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 And Analysis: 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 And Dissemination: Ethics approval number: IRB(2023)K019.01. The findings will be shared regardless of the effect's direction.
Trial Registration Number: NCT05923528.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10900569 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2023-078727 | DOI Listing |
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