Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye - Trial NCT05923528
Access comprehensive clinical trial information for NCT05923528 through Pure Global AI's free database. This phase not specified trial is sponsored by He Eye Hospital and is currently Not yet recruiting. The study focuses on Dry Eye. Target enrollment is 116 participants.
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Study Focus
Sponsor & Location
He Eye Hospital
Timeline & Enrollment
N/A
Jul 01, 2023
Dec 31, 2023
Primary Outcome
Non-invasive tear breakup time (NITBUT)
Summary
The lipid layer of the tear film is critical to maintaining the integrity of the tear film
 and deficiency in the tear film lipid layer (TFLL) is the cause of evaporative dry eye (EDE)
 in approximately 80% of dry eye disease patients, resulting in excessive evaporation
 (so-called hyperevaporative dry eye). This study protocol was 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.
 
 EDE patients will be randomly divided into IPL, HEM, VTPS, and EMD groups and will be
 followed up for four weeks. The primary outcome measure will be non-invasive tear breakup
 time (NITBUT). The secondary outcome measures will include, tear film lipid layer score
 (TFLL), meibomian gland function and secretion quality change from baseline conjunctival and
 cornea staining (CFS) with fluorescein and lissamine, tear meniscus height (TMH),
 conjunctival hyperemia (RS score) and ocular surface disease index (OSDI) questionnaire.
 Additionally, adverse events also were monitored and documented.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05923528
Device Trial