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

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Meibomian Gland Dysfunction; Dry Eye Disease (DED)

Treatments: Device: Intense pulsed light; Drug: Ocular lubricant; Device: thermal pulsation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06745089

IRB number: YM111073F

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

IPL arm

Experimental group

Treatment:

Device: Intense pulsed light

TPT arm

Experimental group

Treatment:

Device: thermal pulsation therapy

Control arm

Active Comparator group

Treatment:

Drug: Ocular lubricant