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

December 17, 2024 updated by: Wen-Chuan Kuo, National Yang Ming Chiao Tung University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Institute of Biophotonics, National Yang Ming Chiao Tung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
Drug: Ocular lubricant
Ocular lubricants moisturize the ocular surface.
Experimental: IPL arm
Device: Intense pulsed light
Intense pulsed light exerts photothermal, photochemical effects, and photobiomodulation on meibomian glands.
Experimental: TPT arm
Device: thermal pulsation therapy
Thermal pulsation therapy utilizes local heating and massage on the eyelids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI) questionnaire
Time Frame: From enrollment to the end of post-treatment follow-up at 5 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming Chiao Tung University

Collaborators

National Health Research Institutes, Taiwan
Nobel Eye Institute
National Science and Technology Council of Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Actual)

June 21, 2023

Study Completion (Actual)

March 10, 2024

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB number: YM111073F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Meibomian Gland Dysfunction

Clinical Trials on Intense pulsed light

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe