Trial Outcomes & Findings for SDOCT-GMPE Software (NCT NCT02235454)
NCT ID: NCT02235454
Last Updated: 2017-07-26
Results Overview
Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
imaging approximately 10 minutes
Results posted on
2017-07-26
Participant Flow
Participant milestones
| Measure |
Glaucoma Arm
Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Glaucoma Arm
Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
SDOCT-GMPE Software
Baseline characteristics by cohort
| Measure |
Glaucoma Arm
n=55 Participants
Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma
|
|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: imaging approximately 10 minutesPopulation: All usable images of one eye of each participant
Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).
Outcome measures
| Measure |
Glaucoma Arm
n=49 Participants
Consecutive patients with glaucoma will undergo non-invasive OCT imaging
SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma
|
|---|---|
|
Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)
|
0.70 correlation coefficient
|
Adverse Events
Glaucoma Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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