Meibography and Tear Scan Using the Oculus Keratograph 4

Meibomian Gland Dysfunction Clinical Trial

— KITCHENER  

Official title:

Meibography and Tear Scan Using the Oculus Keratograph 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382108
• Other study ID #: P/374/11/CCLR
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: October 31, 2013
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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):

1. Composite symptom score of = 12 on the OSDI questionnaire

2. 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):

1. Composite symptom score of = 13 on the OSDI questionnaire

2. 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.	No
Primary	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.	Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.	No
Primary	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.	Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.	No