Dry Eye Disease (DED)NCT06745089
Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial
A study testing Intense pulsed light, thermal pulsation therapy and Ocular lubricant in people with Dry Eye Disease (DED) and Meibomian Gland Dysfunction, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dry Eye Disease (DED), Meibomian Gland Dysfunction
- What is being tested?
- Intense pulsed light, thermal pulsation therapy and Ocular lubricant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2022to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- allergic to topical anesthetics
- sunbathe in recent one month
- periocular fillers
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Institute of Biophotonics, National Yang Ming Chiao Tung University
Taipei
About this study
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:
Read more
- 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
- Being tested
- Intense pulsed light, thermal pulsation therapy, Ocular lubricant
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense pulsed lightDevice
Intense pulsed light exerts photothermal, photochemical effects, and photobiomodulation on meibomian glands.
thermal pulsation therapyDevice
Thermal pulsation therapy utilizes local heating and massage on the eyelids.
Ocular lubricantDrug
Ocular lubricants moisturize the ocular surface.
| Study group | Role | What they receive |
|---|---|---|
| IPL arm | Experimental | Not described Receives: Device: Intense pulsed light |
| TPT arm | Experimental | Not described Receives: Device: thermal pulsation therapy |
| Control arm | Active comparator | Not described Receives: Drug: Ocular lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI) questionnaire
Ocular Surface Disease Index (OSDI) questionnaire was assessed by participants in each follow-ups.
Measured: From enrollment to the end of post-treatment follow-up at 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start13 Jul 2022
- Primary completion21 Jun 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Eye Institute, National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Wen-Chuan Kuo, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745089
- Sponsor's protocol ID
- IRB number: YM111073F
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06745089
- Acronym / sponsor ID
- IRB number: YM111073F
- Conditions
- Dry Eye Disease (DED), Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Nobel Eye Institute, National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPL arm | Experimental | Device: Intense pulsed light |
| TPT arm | Experimental | Device: thermal pulsation therapy |
| Control arm | Active comparator | Drug: Ocular lubricant |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intense pulsed lightIntense pulsed light exerts photothermal, photochemical effects, and photobiomodulation on meibomian glands. | Device | IPL arm |
| thermal pulsation therapyThermal pulsation therapy utilizes local heating and massage on the eyelids. | Device | TPT arm |
| Ocular lubricantOcular lubricants moisturize the ocular surface. | Drug | Control arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense pulsed light, thermal pulsation therapy and Ocular lubricant in people with Dry Eye Disease (DED) and Meibomian Gland Dysfunction, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) questionnaire (time frame: From enrollment to the end of post-treatment follow-up at 5 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.