Meibomian Gland DysfunctionKITCHENERNCT01382108
Meibography and Tear Scan Using the Oculus Keratograph 4
An observational study of Meibomian Gland Dysfunction, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to look at both the meibomian glands and the tear film using a new clinical instrument marketed in Canada which was recently acquired by the Centre for Contact Lens Research. Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Oct 2012
- Phase
- Observational
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Non-contact lens wearers will be recruited using CCLR records and advertising approved by the UW Office of Research Ethics
Who may be able to join
- Is at least 17 years of age and has full legal capacity to volunteer
- Has read and signed an information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Has had an ocular examination in the last two years
- Clinical criteria defining non-dry eye (controls) for study inclusion (Group 1):
- Composite symptom score of ≤ 12 on the OSDI questionnaire
Show all 11Show fewer
- Meibum secretion quality score of 0 (grade 0-3) at the central eight meibomian glands of the lower lid, in both eyes. Secretion quality score (grade 0-3):
- Grade 0 = normal, clear oil expressed (i.e., cooking oil appearance) Grade 1= opaque, diffusely turbid, normal viscosity Grade 2 = opaque, increased viscosity Grade 3 = inspissated (i.e., toothpaste-like appearance) or no expressed material Clinical criteria defining MGD dry eye for study inclusion (Group 2):
- Composite symptom score of ≥ 13 on the OSDI questionnaire
- Meibum secretion quality score ≥ 1.0 (grade 0-3) at the central eight meibomian glands of the lower lid, in both eyes. Secretion quality score (grade 0-3):
- Grade 0 = normal, clear oil expressed (i.e., cooking oil appearance) Grade 1 = opaque, diffusely turbid, normal viscosity Grade 2 = opaque, increased viscosity Grade 3 = inspissated (i.e., toothpaste-like appearance) or no expressed material
Who cannot join
- Is a current contact lens wearer
- Has any ocular disease
- Is using any topical medications that may affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
The purpose of this study is to look at both the meibomian glands and the tear film using a new clinical instrument marketed in Canada which was recently acquired by the Centre for Contact Lens Research. These will be compared between two groups of individuals, one group with visible meibomian gland dysfunction (MGD) and one group of individuals with normal meibomian gland appearance. The hypothesis is that there will be a difference between normal individuals and individuals with MGD with respect to the appearance of the meibomian glands and certain tear film attributes.
Read the detailed description
Meibomian gland dysfunction (MGD) is a common clinical condition and a major cause of evaporative dry eye with associated discomfort, visual disturbance and contact lens intolerance. In MGD, meibum is often abnormal, progressively changing in color from clear to yellow and in consistency from liquid to thick and toothpaste-like. Evaluation of the meibomian glands (MG) and lipid layer is vital. In a typical clinical setting, lid and lid margin evaluation is often performed via slitlamp biomicroscopy; however, the structure of the meibomian glands is often not clearly visualized when a slit lamp is used in isolation. Trans-illumination of the lids is necessary to clearly view these glands.
To date, infrared meibography has been the only method available for the assessment of meibomian gland structure. It is primarily regarded as a laboratory-specific procedure for meibomian gland drop out assessment in people suffering from MGD. Recently, the Keratograph 4 was released by OCULUS (Wetzlar, Germany). In addition to corneal and contact lens assessment features, the Keratograph 4 offers a tear film (TF) scan module able to objectively assess tear break-up time (TBUT) with a colour coded map highlighting the regions of tear break up. High-resolution images of tear meniscus can also be obtained and used for subjective assessment of tear meniscus height (TMH) with the help of built-in software. Preliminary research at the Centre for Contact Lens Research has demonstrated its ability to capture meibography images of the upper and lower lids.
The objectives of this study are to collect meibography, TBUT and TMH data using the Keratograph 4 in normal participants (no MGD) and participants with MGD and to compare these between the two groups and before and after the use of a meibomian gland evaluator. The primary outcome variables are meibography images, TBUT and TMH.
The study hypothesis is that here will be a difference between normal participants and participants with MGD, with respect to meibography images (MG drop out), TBUT measurements (area and time of break up) and TMH measurements.
- Conditions
- Meibomian Gland Dysfunction
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal participants | Not described | |
| Meibomian Gland Dysfunction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)
Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
The meibomium gland dropout score subjective grading scale:
0 = no loss of mebomium glands
- = area of meibomium gland loss less than 33%
- = area of meibomium gland loss between 33% and 67%
- = area of meibomium gland loss more than 67%.
Measured: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.
Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
Measured: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.
Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
Measured: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionOct 2012
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.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Centre for Contact Lens Research, University of Waterloo
- Investigators
- Lyndon Jones, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382108
- Sponsor's protocol ID
- P/374/11/CCLR
- Acronym
- KITCHENER
- Status last verified
- Oct 2013
- First submitted
- 21 Jun 2011
- Last updated
- 26 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meibography and Tear Scan Using the Oculus Keratograph 4
- ClinicalTrials.gov ID
- NCT01382108
- Acronym / sponsor ID
- KITCHENER / P/374/11/CCLR
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 26 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at both the meibomian glands and the tear film using a new clinical instrument marketed in Canada which was recently acquired by the Centre for Contact Lens Research. These will be compared between two groups of individuals, one group with visible meibomian gland dysfunction (MGD) and one group of individuals with normal meibomian gland appearance. The hypothesis is that there will be a difference between normal individuals and individuals with MGD with respect to the appearance of the meibomian glands and certain tear film attributes.
Detailed description
Meibomian gland dysfunction (MGD) is a common clinical condition and a major cause of evaporative dry eye with associated discomfort, visual disturbance and contact lens intolerance. In MGD, meibum is often abnormal, progressively changing in color from clear to yellow and in consistency from liquid to thick and toothpaste-like. Evaluation of the meibomian glands (MG) and lipid layer is vital. In a typical clinical setting, lid and lid margin evaluation is often performed via slitlamp biomicroscopy; however, the structure of the meibomian glands is often not clearly visualized when a slit lamp is used in isolation. Trans-illumination of the lids is necessary to clearly view these glands.
To date, infrared meibography has been the only method available for the assessment of meibomian gland structure. It is primarily regarded as a laboratory-specific procedure for meibomian gland drop out assessment in people suffering from MGD. Recently, the Keratograph 4 was released by OCULUS (Wetzlar, Germany). In addition to corneal and contact lens assessment features, the Keratograph 4 offers a tear film (TF) scan module able to objectively assess tear break-up time (TBUT) with a colour coded map highlighting the regions of tear break up. High-resolution images of tear meniscus can also be obtained and used for subjective assessment of tear meniscus height (TMH) with the help of built-in software. Preliminary research at the Centre for Contact Lens Research has demonstrated its ability to capture meibography images of the upper and lower lids.
The objectives of this study are to collect meibography, TBUT and TMH data using the Keratograph 4 in normal participants (no MGD) and participants with MGD and to compare these between the two groups and before and after the use of a meibomian gland evaluator. The primary outcome variables are meibography images, TBUT and TMH.
The study hypothesis is that here will be a difference between normal participants and participants with MGD, with respect to meibography images (MG drop out), TBUT measurements (area and time of break up) and TMH measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal participants | – | – |
| Meibomian Gland Dysfunction | – | – |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-contact lens wearers will be recruited using CCLR records and advertising approved by the UW Office of Research Ethics
Key inclusion criteria (11 listed)
- Is at least 17 years of age and has full legal capacity to volunteer
- Has read and signed an information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Has had an ocular examination in the last two years
- Clinical criteria defining non-dry eye (controls) for study inclusion (Group 1):
Key exclusion criteria (4 listed)
- Is a current contact lens wearer
- Has any ocular disease
- Is using any topical medications that may affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals to be used in 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.
Primary outcome
Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)
Time frame: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator. The meibomium gland dropout score subjective grading scale: 0 = no loss of mebomium glands 1. = area of meibomium gland loss less than 33% 2. = area of meibomium gland loss between 33% and 67% 3. = area of meibomium gland loss more than 67%.
Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.
Time frame: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.
Time frame: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Meibomian Gland Dysfunction
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Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Not yet recruiting
The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction
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.
Lyndon Jones, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction, run by University of Waterloo at 1 site in Canada.
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 11 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 26 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 Canada. 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 26 Nov 2013). 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?
Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6) (time frame: Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.). The study lists 3 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 26 Nov 2013.