Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction

Not Applicable

Recruiting

• Conditions: MGD-Meibomian Gland Dysfunction

• Registration Number: NCT06468930
• Lead Sponsor: Chulalongkorn University

Brief Summary

The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD).

The main question it aims to answer is does the adjunctive of low-level light therapy (LLLT) to intense pulsed light (IPL) provide more beneficial treatment effects than intense pulsed light (IPL) alone in treating meibomian gland dysfunction (MGD) patients?

Participants will be randomized into 2 groups: adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) group (ALLLT +IPL) and IPL alone group.

Detailed Description

In both the IPL group and the ALLLT+IPL group, the doctor will administer IPL therapy to each participant and apply the Light Modulation® special facial mask to their faces. The assistant nurse will activate the light power, ensuring that the doctor remains blind to treatment allocation. Participants in both groups will receive a conventional treatment for MGD including warm compression and lid hygiene. Moreover, all participants will be advised to use preservative-free artificial tears 4 times daily throughout the study.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-06-16
• Study First Posted: 2024-06-21
• Study Start: 2024-10-02
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

• History of previous ocular trauma or surgery within the past six months
• Contact lens-wearing patients
• Patients with skin-pigmented lesions in the treatment area
• Pregnancy or breastfeeding patients
• Patients with any uncontrolled ocular or systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lipid layer thickness (LLT)	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	Lipid layer thickness will be evaluated using Lipiview® II interferometer (TearScience®, Johnson \& Johnson Vision, California, USA). The thickness of the lipid layer is then calculated from the interference pattern and expressed in interferometric color units (ICU), where 1 ICU reflects approximately 1 nm of lipid layer thickness.

Secondary Outcome Measures

Name	Time	Method
Meibum quality score	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	Meibum quality grade will be evaluated on central 8 glands at the lower lid with grade 0 indicating clear meibum, 1 indicating cloudy meibum, 2 indicating cloudy particulate meibum, and 3 indicating inspissated, like toothpaste meibum.
Tear film break-up time (TBUT)	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	TBUT will be measured using the standard fluorescein staining method.
Meibum expressibility score	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	Meibum expressibility score will be evaluated on central 8 glands at the lower lid with 0 indicating all glands expressible, 1 indicating 3-4 glands expressible, 2 indicating 1-2 glands expressible, and 3 indicating no gland expressible.
Meiboscore	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	Meibography will be evaluated using Lipiview® II interferometer (TearScience®, Johnson \& Johnson Vision, California, USA) Meiboscore will be graded according to meibomian gland dropout; grade 0 indicates no loss of meibomian gland, grade 1 indicates less than 25% gland loss, grade 2 indicates 25-50% gland loss, grade 3 indicates 50-75% gland loss, and grade 4 indicates more than 75% gland loss.
Conjunctival and corneal staining:	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	Conjunctival and corneal staining will be evaluated using National Eye Institute (NEI) industry scale ranging from 0-33.
Ocular surface disease index (OSDI) scores	baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment	OSDI scores will be evaluated using a validated questionnaire, with a total score ranging from 0-100. Higher values indicating greater symptom severity; normal (\<12), mild (13-22) moderate (23-32) or severe (33-100).
Tear cytokines levels	baseline and 12 weeks post treatment	Tear samples were collected using a Schirmer strip placed at the inferior fornix without anesthesia waiting for 5 minutes, then the strip will be kept in a 2 ml centrifuge tube. The samples were stored at -20°C for further assays.

Trial Locations

Locations (1)

King Chulalongkorn memorial hospital; 🇹🇭 Bangkok, Thailand