Trial Outcomes & Findings for Meibography and Tear Scan Using the Oculus Keratograph 4 (NCT NCT01382108)
NCT ID: NCT01382108
Last Updated: 2013-11-26
Results Overview
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%.
COMPLETED
39 participants
Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.
2013-11-26
Participant Flow
39 non-contact lens wearers were recruited using CCLR records
Participant milestones
| Measure |
Normal Participants
Participants without Meibomian Gland Dysfunction
|
Meibomian Gland Dysfunction
Participants with Meibomian Gland Dysfunction
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Meibography and Tear Scan Using the Oculus Keratograph 4
Baseline characteristics by cohort
| Measure |
Normal Participants
n=20 Participants
Participants without meibomian gland dysfunction
|
Meibomian Gland Dysfunction
n=19 Participants
Participants with Meibomian Gland Dysfunction
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
57.3 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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%.
Outcome measures
| Measure |
Normal Participants
n=20 Participants
Participants without Meibomian Gland Dysfunction
|
Meibomian Gland Dysfunction
n=19 Participants
Participants with Meibomian Gland Dysfunction
|
|---|---|---|
|
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)
Subjective grading (0-6) (baseline)
|
1.3 units on a scale
Standard Deviation 1.0
|
3.1 units on a scale
Standard Deviation 1.1
|
|
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)
Subjective grading (0-6) (after 10 minutes)
|
1.3 units on a scale
Standard Deviation 1.0
|
3.1 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Normal Participants
n=20 Participants
Participants without Meibomian Gland Dysfunction
|
Meibomian Gland Dysfunction
n=19 Participants
Participants with Meibomian Gland Dysfunction
|
|---|---|---|
|
Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.
TBUT (baseline)
|
9.0 seconds
Standard Deviation 6.6
|
6.7 seconds
Standard Deviation 6.8
|
|
Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.
TBUT (after 10 minutes)
|
6.8 seconds
Standard Deviation 6.1
|
7.6 seconds
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Normal Participants
n=20 Participants
Participants without Meibomian Gland Dysfunction
|
Meibomian Gland Dysfunction
n=19 Participants
Participants with Meibomian Gland Dysfunction
|
|---|---|---|
|
Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.
TMH (baseline)
|
0.2 mm
Standard Deviation 0.1
|
0.2 mm
Standard Deviation 0.1
|
|
Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.
TMH (after 10 minutes)
|
0.2 mm
Standard Deviation 0.1
|
0.2 mm
Standard Deviation 0.1
|
Adverse Events
Normal Participants
Meibomian Gland Dysfunction
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place