The Effect of Gland Expression on the Regeneration of Meibomian Gland

NCT06163105 | Completed

• 1 other identifier: 0868/66
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Meibomian gland expression; squeezing; Regeneration; Morphology

Outcome Measures

Primary Outcomes (1)

• Meibomian gland dropout percentage

  The dropout percentage of upper and lower eyelid is calculated by (Area of Meibomian gland dropout) / (Area of tarsal plate)\*100%. Non-contact infrared Meibography is carried out using Oculus Keratograph 5M with upper and lower eyelids everted consecutively. To calculate the dropout area percentage of each eyelid, the investigator analyzes the images by utilizing the ImageJ software.

  Baseline, week 4, week 8, week 12

Secondary Outcomes (7)

• Meibomian gland morphology

  Baseline, week 4, week 8, week 12

• Lipid layer thickness

  Baseline, week 4, week 8, week 12

• Lid margin abnormality

  Baseline, week 4, week 8, week 12

• Meibum quality

  Baseline, week 4, week 8, week 12

• Meibum expressibility

  Baseline, week 4, week 8, week 12

Study Arms (2)

Meibomian gland expression (MGX)

EXPERIMENTAL

* In-office MGX every 2 weeks * Lid hygiene at home once daily for 12 weeks * Preservative-free artificial tears (0.18% sodium hyaluronate) 4 times daily for 12 weeks

Procedure: Meibomian gland expression (MGX)

Control group

NO INTERVENTION

* Lid hygiene at home once daily for 12 weeks * Preservative-free artificial tears (0.18% sodium hyaluronate) 4 times daily for 12 weeks

Interventions

Meibomian gland expression (MGX) PROCEDURE

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

Also known as: Meibomian gland squeezing

Meibomian gland expression (MGX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of obstructive MGD
• Visible Meibomian gland dropout of upper and lower eyelid from grade 1 to grade 2 (Arita's meiboscale)
• If both eyes meet above criteria, only right eye is chosen

You may not qualify if:

• Diagnosis with secondary MGD
• Having any eyedrop other than eye lubricant within the last 3 months
• Any kind of eyelid treatment related to MGD within the last 6 months
• History of ocular trauma, ocular surface surgery or eyelid surgery
• History of intraocular surgery less than 6 months
• Eyelid botulinum toxin injection within the last 6 months
• Ocular diseases other than dry eye
• Pregnant or breast-feeding
• Wearing contact lens
• Using any hormones therapy, anti-inflammatory drugs, tetracycline and macrolides
• Refuse to participate in the study

Sponsors & Collaborators

• Chulalongkorn University: lead
• King Chulalongkorn Memorial Hospital: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: October 3, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

TH (1)