Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial
NCT06745089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-12-20
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
Interventions
- DEVICE
-
Intense pulsed light
Intense pulsed light exerts photothermal, photochemical effects, and photobiomodulation on meibomian glands.
- DEVICE
-
thermal pulsation therapy
Thermal pulsation therapy utilizes local heating and massage on the eyelids.
- DRUG
-
Ocular lubricant
Ocular lubricants moisturize the ocular surface.
Sponsors & Collaborators
-
Nobel Eye Institute
collaborator UNKNOWN -
National Science and Technology Council, Taiwan
collaborator OTHER_GOV -
National Health Research Institutes, Taiwan
collaborator OTHER -
National Yang Ming Chiao Tung University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-13
- Primary Completion
- 2023-06-21
- Completion
- 2024-03-10
Countries
- Taiwan
Study Locations
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