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

NCT06468930 | Recruiting

• 1 other identifier: 0666/66
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

MGD-Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Meibum quality score

  baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment

• Meibum expressibility score

  baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment

• Meiboscore

  baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment

• Tear film break-up time (TBUT)

  baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment

• Conjunctival and corneal staining:

  baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment

Study Arms (2)

ALLLT + IPL group

EXPERIMENTAL

Participants will receive a session of IPL therapy followed by LLLT therapy, once weekly for 4 weeks (total 4 treatment sessions). 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. The 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 a light-emitting diode (LED) system.

Device: Low-level light therapy (LLLT); Device: Intense pulsed light (IPL)

IPL alone group

ACTIVE COMPARATOR

The IPL alone group will receive only a session of IPL therapy, once weekly for 4 weeks (total 4 treatment sessions). 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, similar to the combined group. Additionally, the special facial mask will also be placed on the participant's face for 15 minutes with no light power applied.

Device: Intense pulsed light (IPL)

Interventions

Low-level light therapy (LLLT) DEVICE

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.

ALLLT + IPL group

Intense pulsed light (IPL) DEVICE

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

ALLLT + IPL group; IPL alone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn memorial hospital

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Low-Level Light Therapy; Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Chatchada Kharuhayothin

  Ophthalmology department, Faculty of medicine, Chulalongkorn university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chatchada Kharuhayothin

CONTACT

+66922496151; chatchada.kharuhayothin@gmail.com

Lita Uthaithammarat

CONTACT

+66928235694; lita.t@chula.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: June 21, 2024
• Study Start: October 2, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)