Clinical trial NCT06468930: Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction
Official title: Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MGD-Meibomian Gland Dysfunction
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* MGD severity level 2 and above according to the international workshop on MGD
* Fitzpatrick skin type of 1-4 according to sun sensitivity characteristics and appearance of the skin color

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

Primary outcomes:
measure: Lipid layer thickness (LLT)
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Secondary outcomes:
measure: Meibum quality score
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
measure: Meibum expressibility score
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
measure: Meiboscore
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
measure: Tear film break-up time (TBUT)
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
measure: Conjunctival and corneal staining:
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
measure: Ocular surface disease index (OSDI) scores
timeFrame: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
measure: Tear cytokines levels
timeFrame: baseline and 12 weeks post treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn memorial hospital
Study officials:
affiliation: Ophthalmology department, Faculty of medicine, Chulalongkorn university
name: Chatchada Kharuhayothin
role: PRINCIPAL_INVESTIGATOR
References: