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NCT Number: NCT06745089

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

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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Biophotonics, National Yang Ming Chiao Tung University

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intense Pulsed Light

Device

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

thermal pulsation therapy

Device

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

Ocular lubricant

Drug

Ocular lubricants moisturize the ocular surface.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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