Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction
NCT Number: NCT06468930
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: MGD-Meibomian Gland Dysfunction
Interventions: DEVICE: Low-level light therapy (LLLT)|DEVICE: Intense pulsed light (IPL)
Sponsor: Chulalongkorn University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-04

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.

Primary Outcome Measures: Lipid layer thickness (LLT), 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., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Secondary Outcome Measures: Meibum quality score, 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., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment|Meibum expressibility score, 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., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment|Meiboscore, 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., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment|Tear film break-up time (TBUT), TBUT will be measured using the standard fluorescein staining method., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment|Conjunctival and corneal staining:, Conjunctival and corneal staining will be evaluated using National Eye Institute (NEI) industry scale ranging from 0-33., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment|Ocular surface disease index (OSDI) scores, 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)., baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment|Tear cytokines levels, 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., baseline and 12 weeks post treatment