Meibomian Gland Dysfunction (MGD)NCT01683318
Treatment of Meibomian Gland Dysfunction
A study testing Thermal Pulsation therapy in people with Meibomian Gland Dysfunction (MGD), run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction (MGD)
- What is being tested?
- Thermal Pulsation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2012to Oct 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.
- At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
- Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
Who cannot join
- Known history of thyroid disorders (diagnosed by physician).
- No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Active ocular infection or pterygium.
- Anticipated necessity to wear contact lens in the duration of the study.
- Living in the same household as another participant of the study.
- Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.
Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.
The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.
- Conditions
- Meibomian Gland Dysfunction (MGD)
- Being tested
- Thermal Pulsation therapy
- 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.
Thermal Pulsation therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow). Receives: Procedure: Thermal Pulsation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular discomfort
Measured: 3 months
Secondary outcomes (6)
Tear Break Up Time (TBUT)
Measured: 3 months
Number of blocked meibomian glands
Measured: 3 months
Corneal fluorescein staining score
Measured: 3 months
To measure the production of tears
Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured.
Measured: 3 months
Tear evaporimetry
Measured: 3 months
Lipid layer thickness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland Dysfunction (MGD)Studies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683318
- Sponsor's protocol ID
- R913/22/2012
- Status last verified
- Sep 2012
- First submitted
- 4 Sep 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.
PubMed 27096755
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT01683318
- Acronym / sponsor ID
- R913/22/2012
- Conditions
- Meibomian Gland Dysfunction (MGD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- National University of Singapore
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- First posted
- 11 Sep 2012 (estimated)
- 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 current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.
Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.
The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Thermal Pulsation therapyPatients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.
- At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
- Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
Key exclusion criteria (7 listed)
- Known history of thyroid disorders (diagnosed by physician).
- No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Active ocular infection or pterygium.
- Anticipated necessity to wear contact lens in the duration of the study.
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 |
|---|---|---|
| Thermal Pulsation therapy | Procedure or surgery | Treatment |
Primary outcome
ocular discomfort
Time frame: 3 months
6 secondary outcomes
Tear Break Up Time (TBUT)
Time frame: 3 months
Number of blocked meibomian glands
Time frame: 3 months
Corneal fluorescein staining score
Time frame: 3 months
To measure the production of tears
Time frame: 3 months
Tear evaporimetry
Time frame: 3 months
Lipid layer thickness
Time frame: 3 months
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 Nov 2013.
- Derived from this study: PubMed 27096755Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.
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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 Thermal Pulsation therapy in people with Meibomian Gland Dysfunction (MGD), run by Singapore National Eye Centre at 1 site in Singapore.
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 3 inclusion and 7 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 Nov 2013. 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 Singapore. 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 discomfort (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683318, which also lists 1 linked publication.
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 Nov 2013.