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The Effect of Gland Expression on the Regeneration of Meibomian Gland

NCT06163105 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-03-17

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the percentage of meibomian gland (MG) dropout in patients who are treated with additional meibomian gland expression (MGX) and in patients who are not. The main question\[s\] it aims to answer are:

* Does additional MGX reverse MG dropout and support regeneration of MG?
* Does additional MGX have better effect on tear film stability, MG function, lid morphology, tear cytokines than lid hygiene alone?

Methods:

Participants will be randomly assigned into MGX group as a treatment group and control group to assess study outcomes. The basic treatment of the 2 groups included lid hygiene once daily and artificial tear. The treatment duration lasts for 12 weeks. Patients will be examined at baseline, at 4-week, 8-week, 12-week visit for MG dropout percentage, MG morphology, lid margin abnormalities, Meibum assessment, tear film, tear cytokines and pain score to see if additional MGX can regenerate MG better than lid hygiene alone.

Conditions

  • Meibomian Gland Dysfunction

Interventions

PROCEDURE

Meibomian gland expression (MGX)

The MGX procedure has a standardized protocol in lid spa at Chula's Refractive Surgery Center every 2 weeks (totally 6 sessions). During the study, all MGX procedures will be conducted by the same nurse following these steps: 1. Topical anesthesia by Tetracaine 0.5% 2. Clean the eyelids by gauzes with commercial available foam 3. Warm the eyelids by Blephasteam machine for 10 minutes 4. Instill Tetracaine 0.5% again 5. Use Mastrota paddle and Q-tip to squeeze the gland 6. Clean the lid margin by commercial available foam 7. Use Moxifloxacin 0.5% eyedrop

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    collaborator OTHER

  • Chulalongkorn University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2025-03-06
Completion
2025-03-06

Countries

  • Thailand

Study Locations

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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 NCT06163105 on ClinicalTrials.gov