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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06745089
Enrollment
45
Registered
2024-12-20
Start date
2022-07-13
Completion date
2024-03-10
Last updated
2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease (DED), Meibomian Gland Dysfunction

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.

Interventions

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

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

Ocular lubricants moisturize the ocular surface.

Sponsors

Nobel Eye Institute
CollaboratorUNKNOWN
National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Health Research Institutes, Taiwan
CollaboratorOTHER
National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ocular Surface Disease Index (OSDI) questionnaireFrom 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026