NCT06468930

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MGD-Meibomian Gland Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-06-21
• Last updated: 2024-11-05

Locations

1 site across 1 country: Thailand