N/A N=39

Meibography and Tear Scan Using the Oculus Keratograph 4

Meibomian Gland Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01382108 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: 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) — 1.3; 3.1; 1.3; 3.1 units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: University of Waterloo
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
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)	1.3; 3.1; 1.3; 3.1	—
PRIMARY Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.	9.0; 6.7; 6.8; 7.6	—
PRIMARY Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.	0.2; 0.2; 0.2; 0.2	—

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.

Eligibility Criteria

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):
Composite symptom score of ≤ 12 on the OSDI questionnaire
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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01382108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.