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

MGD-Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468930
• Other study ID #: 0666/66
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: Chatchada Kharuhayothin
• Phone: +66922496151
• Email: chatchada.kharuhayothin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction
• MGD-Meibomian Gland Dysfunction

Intervention

Device:
• Low-level light therapy (LLLT)
LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in an LED system. The device has an emission power of 100 The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system. The device has an emission power of 100 milliwatts per square centimeter.
• Intense pulsed light (IPL)
The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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