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

Not Applicable

Completed

• Conditions: Dry Eye Disease (DED); Meibomian Gland Dysfunction
• Interventions: Device: Intense pulsed light; Device: thermal pulsation therapy; Drug: Ocular lubricant

• Registration Number: NCT06745089
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-13
• Primary Completion: 2023-06-21
• Study Completion: 2024-03-10
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPL arm	Intense pulsed light	-
TPT arm	thermal pulsation therapy	-
Control arm	Ocular lubricant	-

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI) questionnaire	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.

Trial Locations

Locations (1)

Institute of Biophotonics, National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan