Meibomian Gland DysfunctionNCT03950115
Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
A study testing Intense Pulsed Light (IPL) in people with Meibomian Gland Dysfunction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators are going to Investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Intense Pulsed Light (IPL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2019to 10 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of meibomian gland dysfunction
Who cannot join
- Medical conditions in which IPL is contraindicated (pregnancy, breastfeeding, lupus, and any major uncontrolled health problem).
- Contact lens wearer
- Previous ocular surgery
- Previous thermal treatment for dry eye disease (e.g. LipiFlow)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are going to Investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction.
Read the detailed description
Enrolled patients are going to be randomly assigned to two groups. All of the patients will undergo four treatment sessions in total, which are two weeks apart. Group 1 will undergo two sessions of intense pulsed light therapy with meibomian gland expression, as well as two sessions of intense pulsed light alone. Group 2 will receive two sessions of intense pulsed light therapy alone, and two sessions of intense pulsed light therapy with meibomian gland expression. The following parameters will be measured at baseline, 2 weeks after the second treatment session, and 2 weeks after the fourth treatment session: tearfilm break-up time, Oxford grade for corneal staining, meibomian gland expressibility, meibum quality, and ocular surface disease index.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Intense Pulsed Light (IPL)
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Pulsed Light (IPL)Device
Also called Meibomian gland expression
IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading. Receives: Device: Intense Pulsed Light (IPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline tearfilm break-up time at 2 weeks after the last treatment session
Measured: Baseline and 2 weeks after the last treatment session
Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session
Oxford grade for staining was assessed on a scale of 0 to 5. It was scaled according to the degree of corneal staining as follow: 0 (absent), 1 (minimal), 2 (mild), 3 (moderate), 4 (marked), and 5 (severe)
Measured: Baseline and 2 weeks after the last treatment session
Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session
The meibomian gland expressibility was assessed on a scale of 0 to 3 in five glands on the central lower lid. It was scaled according to the number of glands expressible, as follows: 0 (all glands), 1 (three to four glands), 2 (one to two glands) and 3 (no glands)
Measured: Baseline and 2 weeks after the last treatment session
Change from baseline meibum quality score at 2 weeks after the last treatment session
The meibum quality score were divided into the following four degrees: 0 (clear), 1 (cloudy), 2 (granular), and 3 (toothpaste)
Measured: Baseline and 2 weeks after the last treatment session
Change from baseline ocular surface disease index at 2 weeks after the last treatment session
The ocular surface diseases index score range from 0 to 100 based on the result of standardized ocular surface disease index questionnaire. Higher value represent worse subjective symptom.
Measured: Baseline and 2 weeks after the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start18 Apr 2019
- Primary completion18 Feb 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tae-young chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950115
- Sponsor's protocol ID
- 2019-04-066
- Status last verified
- May 2022
- First submitted
- 22 Apr 2019
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT03950115
- Acronym / sponsor ID
- 2019-04-066
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 15 May 2019 (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 investigators are going to Investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction.
Detailed description
Enrolled patients are going to be randomly assigned to two groups. All of the patients will undergo four treatment sessions in total, which are two weeks apart. Group 1 will undergo two sessions of intense pulsed light therapy with meibomian gland expression, as well as two sessions of intense pulsed light alone. Group 2 will receive two sessions of intense pulsed light therapy alone, and two sessions of intense pulsed light therapy with meibomian gland expression. The following parameters will be measured at baseline, 2 weeks after the second treatment session, and 2 weeks after the fourth treatment session: tearfilm break-up time, Oxford grade for corneal staining, meibomian gland expressibility, meibum quality, and ocular surface disease index.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Intense Pulsed Light (IPL)IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of meibomian gland dysfunction
Key exclusion criteria (4 listed)
- Medical conditions in which IPL is contraindicated (pregnancy, breastfeeding, lupus, and any major uncontrolled health problem).
- Contact lens wearer
- Previous ocular surgery
- Previous thermal treatment for dry eye disease (e.g. LipiFlow)
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 Light (IPL)Also: Meibomian gland expressionIPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading. | Device | Group 1 |
Primary outcome
Change from baseline tearfilm break-up time at 2 weeks after the last treatment session
Time frame: Baseline and 2 weeks after the last treatment session
Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session
Time frame: Baseline and 2 weeks after the last treatment session
Oxford grade for staining was assessed on a scale of 0 to 5. It was scaled according to the degree of corneal staining as follow: 0 (absent), 1 (minimal), 2 (mild), 3 (moderate), 4 (marked), and 5 (severe)
Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session
Time frame: Baseline and 2 weeks after the last treatment session
The meibomian gland expressibility was assessed on a scale of 0 to 3 in five glands on the central lower lid. It was scaled according to the number of glands expressible, as follows: 0 (all glands), 1 (three to four glands), 2 (one to two glands) and 3 (no glands)
Change from baseline meibum quality score at 2 weeks after the last treatment session
Time frame: Baseline and 2 weeks after the last treatment session
The meibum quality score were divided into the following four degrees: 0 (clear), 1 (cloudy), 2 (granular), and 3 (toothpaste)
Change from baseline ocular surface disease index at 2 weeks after the last treatment session
Time frame: Baseline and 2 weeks after the last treatment session
The ocular surface diseases index score range from 0 to 100 based on the result of standardized ocular surface disease index questionnaire. Higher value represent worse subjective symptom.
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 13 May 2022.
- Individual participant dataSharing planned: No
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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 (IPL) in people with Meibomian Gland Dysfunction, run by Samsung Medical Center at 1 site in South Korea.
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 4 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 13 May 2022. 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 South Korea. 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?
Change from baseline tearfilm break-up time at 2 weeks after the last treatment session (time frame: Baseline and 2 weeks after the last treatment session). The study lists 5 primary outcomes in all. 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 13 May 2022.