Meibomian Gland DysfunctionNCT01769105
Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime
A study testing Lipiflow and Lid hygiene regime in people with Meibomian Gland Dysfunction, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Lipiflow and Lid hygiene regime
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with meibomian gland dysfunction requiring treatment (defined below),
- who have given their written consent to the study.
- Meibomian gland dysfunction requiring treatment is classified by us as:
- Speed score> 7, Lipiview <61 nm, MGE <5 of 15 open glands
Who cannot join
- Excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study
- Systemic medication with tetracyclin derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD that started <3 months before baseline examination
- Topical cyclosporine-A or steroids that started <1 month before baseline examination
- Ocular surgery or trauma <3 months before baseline examination
- Any eyelid abnormalities
- Systemic diseases resulting in dry eye.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deparment of ophthalmology, Heinrich-Heine-University
Düsseldorf, D-40225
About this study
Official title: Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime
Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However, treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia followed by lid massage and lid margin cleansing over several months. To the best of the investigators knowledge this is the first randomized prospective study to compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene regime.
The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene regime.
Read the detailed description
Once a patient has been identified as a possible candidate for the study, he/she is first informed verbally and in writing about the study. After signing the consent form he/she will be randomized to either the Lipiflow® treatment (Lipiflow® group) or alternatively be given an instruction sheet and a verbal explanation for lid warming and massage (lid hygiene group). After 3 month a cross-over of the lid hygiene group to the Lipiflow® group is conducted.
A full examination is performed before and 4 weeks and 3 months after therapy. All tests are performed by a physician or trained graduate students of the Department of Ophthalmology, Heinrich-Heine University. The examiner is blinded, i.e. he does not know which treatment the patient will receive or receiving.
Treatment Lipiflow®:
The automated thermal pulsation with Lipiflow® provides is a low risk therapy. After local anesthesia the applicators are inserted. These look like a kind of goggles and consist of two parts which embrace the eyelids from the front and from behind. Through the rear part heat is applied to a maximum of 42.5° C. By isolating the heat remains on the eyelid limited. Through the front part the gland a massage is performed. The treatment takes 12 minutes per eye and can be done depending on the patient's wishes simultaneously or one eye after the other. The therapy is approved by the FDA as a medical technical innovation and has also been approved by ISO and CE Mark certification for use in Europe. Irritation or minor trauma of the eyelids and the conjunctiva and cornea, as well as a violation of the eyelids and the conjunctiva and cornea are theoretically possible, but extremely unlikely. Permanent damages to the eyes have not been reported in the literature.
In the unlikely event, that complications occur during treatment, requiring an additional treatment, this is performed in the department of ophthalmology of the Heinrich-Heine University Duesseldorf.
Test parameters:
At any time of investigation, the following parameters are evaluated:
Lipiview®, Tear Lab®, Schirmer test, break-up time, corneal and conjunctival fluorescein staining, Meibomian gland evaluation (MGE), examination of the eyelids, Meibography, OSDI score, SPEED score
All test parameters are established procedures and have in common a very low risk of harm to the patient. In detail:
The Lipiview® is a device that quantifies the thickness of the lipid layer of the tear film using interferometry. For this the patient looks into a kind of camera while recordings of his tear film are made, which are then analyzed by a computer.
Tear Lab® is a method for measuring tear film osmolarity. A pen-like instrument (the osmometer) is held on the tear meniscus and collects 100 nl tears within fractions of a second in the unit. There is no need for local anaesthesia. By electrical impedance measurement, then the tear film osmolarity is measured. The examiner can then read the values digitally.
The Schirmer test consists of a strip of filter paper that is placed in the conjunctival sac of the patient for five minutes. The filter paper absorbs the tear fluid and the stained by the tear fluid line serves as a measure of tear secretion.
Tear break-up time is the time between a blink and the tear film shows signs of breaking up. In this study this is measured non-invasive with the Oculus-Keratograph 5 M®. The patient looks into a kind of camera while recordings of his tear film are made which are then analyzed by a computer.
Vital corneal and conjunctival epithelium cannot be stained by fluorescein. The dye adheres to nonviable cells. The degree of staining, can be judged by the investigator by slit-lamp examination.
For evaluation of the secreting meibomian glands a specialized device (Meibomian gland evaluator) is used, that provides a defined pressure to the lid. The examiner observes the ducts of the Meibomian glands and assesses how many glands are yielding secretion.
Examination of the eyelids is done using a slit lamp to assess a thickening or a significant vascularisation the lid margin.
To perform meibography the lids are illuminated by infrared light. Functional acini of the glands become clearly visible and can be differentiated from atrophic acini. The number of atrophic meibomian glands can be counted by a score.
OSDI (Ocular-Surface-Disease-Index) and SPEED (Standard Pattern Evaluation of Eye Dryness) are questionnaires to quantify the symptoms of dry eye.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Lipiflow, Lid hygiene regime
- Keywords
- Meibomian Gland Dysfunction, Lipiflow
- 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.
LipiflowDevice
Patients receive a single Lipiflow-treatment
Lid hygiene regimeBehavioural
Patients receive verbal and written instruction to perform lid hygiene twice daily
| Study group | Role | What they receive |
|---|---|---|
| Standard Lid Hygiene Regime | Active comparator | Patients receive detailed verbal and written instruction to perform lid hygiene twice daily Receives: Behavioral: Lid hygiene regime |
| Lipiflow | Active comparator | Patients receive a singe Lipiflow-treatment Receives: Device: Lipiflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Dry Eye Symptoms
The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI)
Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness).
OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms.
Measured: after 3 month compared to baseline value
Secondary outcomes (4)
Change of Break-up-time
break-up-time is measured non-invasive with the Oculus Keratograph 5 M;
The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication.
Measured: after 3 month compared to baseline value
Change in Tear Film Osmolarity
osmolarity is measured with the tear-lab;
The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease.
A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease.
Measured: after 3 month compared to baseline value
Change in Lipid Layer Thickness
lipid layer thickness (LLT) is measured with the Lipiview-interferometer;
High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface.
LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness.
Measured: after 3 month compared to baseline value
Change in Expressible Meibomian Glands
expressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.
Measured: after 3 month compared to baseline value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Finis, MD, Heinrich-Heine University, Duesseldorf
- Investigators
- Gerd Geerling, M.D., Study chair, Deparmtent of ophthalmology, Heinrich-Heine-University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769105
- Sponsor's protocol ID
- HHUAU052012
- Status last verified
- Oct 2014
- First submitted
- 11 Jan 2013
- Last updated
- 7 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Finis D, Hayajneh J, Konig C, Borrelli M, Schrader S, Geerling G. Evaluation of an automated thermodynamic treatment (LipiFlow(R)) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial. Ocul Surf. 2014 Apr;12(2):146-54. doi: 10.1016/j.jtos.2013.12.001. Epub 2014 Jan 22.
PubMed 24725326
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime
- ClinicalTrials.gov ID
- NCT01769105
- Acronym / sponsor ID
- HHUAU052012
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian Gland Dysfunction, Lipiflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However, treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia followed by lid massage and lid margin cleansing over several months. To the best of the investigators knowledge this is the first randomized prospective study to compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene regime.
The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene regime.
Detailed description
Once a patient has been identified as a possible candidate for the study, he/she is first informed verbally and in writing about the study. After signing the consent form he/she will be randomized to either the Lipiflow® treatment (Lipiflow® group) or alternatively be given an instruction sheet and a verbal explanation for lid warming and massage (lid hygiene group). After 3 month a cross-over of the lid hygiene group to the Lipiflow® group is conducted.
A full examination is performed before and 4 weeks and 3 months after therapy. All tests are performed by a physician or trained graduate students of the Department of Ophthalmology, Heinrich-Heine University. The examiner is blinded, i.e. he does not know which treatment the patient will receive or receiving.
Treatment Lipiflow®:
The automated thermal pulsation with Lipiflow® provides is a low risk therapy. After local anesthesia the applicators are inserted. These look like a kind of goggles and consist of two parts which embrace the eyelids from the front and from behind. Through the rear part heat is applied to a maximum of 42.5° C. By isolating the heat remains on the eyelid limited. Through the front part the gland a massage is performed. The treatment takes 12 minutes per eye and can be done depending on the patient's wishes simultaneously or one eye after the other. The therapy is approved by the FDA as a medical technical innovation and has also been approved by ISO and CE Mark certification for use in Europe. Irritation or minor trauma of the eyelids and the conjunctiva and cornea, as well as a violation of the eyelids and the conjunctiva and cornea are theoretically possible, but extremely unlikely. Permanent damages to the eyes have not been reported in the literature.
In the unlikely event, that complications occur during treatment, requiring an additional treatment, this is performed in the department of ophthalmology of the Heinrich-Heine University Duesseldorf.
Test parameters:
At any time of investigation, the following parameters are evaluated:
Lipiview®, Tear Lab®, Schirmer test, break-up time, corneal and conjunctival fluorescein staining, Meibomian gland evaluation (MGE), examination of the eyelids, Meibography, OSDI score, SPEED score
All test parameters are established procedures and have in common a very low risk of harm to the patient. In detail:
The Lipiview® is a device that quantifies the thickness of the lipid layer of the tear film using interferometry. For this the patient looks into a kind of camera while recordings of his tear film are made, which are then analyzed by a computer.
Tear Lab® is a method for measuring tear film osmolarity. A pen-like instrument (the osmometer) is held on the tear meniscus and collects 100 nl tears within fractions of a second in the unit. There is no need for local anaesthesia. By electrical impedance measurement, then the tear film osmolarity is measured. The examiner can then read the values digitally.
The Schirmer test consists of a strip of filter paper that is placed in the conjunctival sac of the patient for five minutes. The filter paper absorbs the tear fluid and the stained by the tear fluid line serves as a measure of tear secretion.
Tear break-up time is the time between a blink and the tear film shows signs of breaking up. In this study this is measured non-invasive with the Oculus-Keratograph 5 M®. The patient looks into a kind of camera while recordings of his tear film are made which are then analyzed by a computer.
Vital corneal and conjunctival epithelium cannot be stained by fluorescein. The dye adheres to nonviable cells. The degree of staining, can be judged by the investigator by slit-lamp examination.
For evaluation of the secreting meibomian glands a specialized device (Meibomian gland evaluator) is used, that provides a defined pressure to the lid. The examiner observes the ducts of the Meibomian glands and assesses how many glands are yielding secretion.
Examination of the eyelids is done using a slit lamp to assess a thickening or a significant vascularisation the lid margin.
To perform meibography the lids are illuminated by infrared light. Functional acini of the glands become clearly visible and can be differentiated from atrophic acini. The number of atrophic meibomian glands can be counted by a score.
OSDI (Ocular-Surface-Disease-Index) and SPEED (Standard Pattern Evaluation of Eye Dryness) are questionnaires to quantify the symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Lid Hygiene Regime | Active comparator | Behavioral: Lid hygiene regimePatients receive detailed verbal and written instruction to perform lid hygiene twice daily |
| Lipiflow | Active comparator | Device: LipiflowPatients receive a singe Lipiflow-treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with meibomian gland dysfunction requiring treatment (defined below),
- who have given their written consent to the study.
- Meibomian gland dysfunction requiring treatment is classified by us as:
- Speed score> 7, Lipiview <61 nm, MGE <5 of 15 open glands
Key exclusion criteria (6 listed)
- Excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study
- Systemic medication with tetracyclin derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD that started <3 months before baseline examination
- Topical cyclosporine-A or steroids that started <1 month before baseline examination
- Ocular surgery or trauma <3 months before baseline examination
- Any eyelid abnormalities
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 |
|---|---|---|
| LipiflowPatients receive a single Lipiflow-treatment | Device | Lipiflow |
| Lid hygiene regimePatients receive verbal and written instruction to perform lid hygiene twice daily | Behavioural | Standard Lid Hygiene Regime |
Primary outcome
Change of Dry Eye Symptoms
Time frame: after 3 month compared to baseline value
The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI) Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness). OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms.
4 secondary outcomes
Change of Break-up-time
Time frame: after 3 month compared to baseline value
Change in Tear Film Osmolarity
Time frame: after 3 month compared to baseline value
Change in Lipid Layer Thickness
Time frame: after 3 month compared to baseline value
Change in Expressible Meibomian Glands
Time frame: after 3 month compared to baseline value
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24725326Finis D, Hayajneh J, Konig C, Borrelli M, Schrader S, Geerling G. Evaluation of an automated thermodynamic treatment (LipiFlow(R)) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial. Ocul Surf. 2014 Apr;12(2):146-54. doi: 10.1016/j.jtos.2013.12.001. Epub 2014 Jan 22.
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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.
Gerd Geerling, M.D. study chair
Deparmtent of ophthalmology, Heinrich-Heine-University, Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiflow and Lid hygiene regime in people with Meibomian Gland Dysfunction, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 4 inclusion and 6 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 7 Oct 2014. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Dry Eye Symptoms (time frame: after 3 month compared to baseline value). 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 NCT01769105, 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 7 Oct 2014.