Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial

NCT06745089 | Completed

• 1 other identifier: IRB number: YM111073F
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand novel treatment methods for meibomian gland dysfunction (MGD)-associated dry eye disease (DED) by comparing two treatment modalities- intense pulsed light (IPL) and thermal pulsation therapy (TPT), to find out the difference of their therapeutic mechanisms and treatment effects, so that eye doctors can give more precise advice to the patients when making treatment decisions. The main questions it aims to answer are:

• What subtype of meibomian gland dysfunction (MGD) better responds to which treatment modality?
• How long do the treatment effects last? Researchers will compare each group (IPL and TPT) to a control group treated with eyedrops. \* Do combined treatment of IPL or TPT with eyedrops show better outcomes than only eyedrops? Participants will:
• Receive different treatment for 2 months according to the group they were randomly allocated to.
• Visit the clinic for checkups after 1 and 3 months after completing the treatment sessions.

Conditions

Dry Eye Disease (DED); Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI) questionnaire

  Ocular Surface Disease Index (OSDI) questionnaire was assessed by participants in each follow-ups.

  From enrollment to the end of post-treatment follow-up at 5 months.

Study Arms (3)

IPL arm

EXPERIMENTAL

Device: Intense pulsed light

TPT arm

EXPERIMENTAL

Device: thermal pulsation therapy

Control arm

ACTIVE COMPARATOR

Drug: Ocular lubricant

Interventions

Intense pulsed light DEVICE

Intense pulsed light exerts photothermal, photochemical effects, and photobiomodulation on meibomian glands.

IPL arm

thermal pulsation therapy DEVICE

Thermal pulsation therapy utilizes local heating and massage on the eyelids.

TPT arm

Ocular lubricant DRUG

Ocular lubricants moisturize the ocular surface.

Control arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals diagnosed with meibomian gland dysfunction (MDG)-associated dry eye disease (DED) that are suitable for intense pulsed light (IPL) and thermal pulsation therapy (TPT)

You may not qualify if:

• ocular surgery or trauma in the recent 3 months
• ocular infection
• eyelid abnormalities (e.g., entropion, ectropion, lagophthalmos, severe ptosis or trichiasis)
• blepharospasm
• eyelid tumor
• severe meibomian gland atrophy
• allergic to topical anesthetics
• sunbathe in recent one month
• periocular fillers

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Nobel Eye Institute: collaborator
• National Science and Technology Council, Taiwan: collaborator
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

Institute of Biophotonics, National Yang Ming Chiao Tung University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Institute of Biophotonics, National Yang Ming Chiao Tung University

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: July 13, 2022
• Primary Completion: June 21, 2023
• Study Completion: March 10, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

TW (1)