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Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye

NCT05923528 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

DEVICE

IPL

IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter

DEVICE

Heated eye mask

Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms

DEVICE

LipiFlow®

LipiFlow® can control the variables of temperature, pressure, and MG expression technique

DEVICE

EyePeace®

The silicone-made flexible hand-held gadget applies regulated, vertical pressure to the closed eyelids.

Sponsors & Collaborators

  • He Eye Hospital

    lead OTHER

Principal Investigators

  • Emmanuel Eric Pazo · He eye specialist hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923528 on ClinicalTrials.gov