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

NCT06468930 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • MGD-Meibomian Gland Dysfunction

Interventions

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.

DEVICE

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

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Chatchada Kharuhayothin · Ophthalmology department, Faculty of medicine, Chulalongkorn university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468930 on ClinicalTrials.gov