SDOCT-GMPE Software
Study Details
Study Description
Brief Summary
The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for spectral domain optical coherence tomography (SDOCT) and if this software is superior to the conventional one that is currently used for SDOCT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The new GMPE software can now identify the ocular structures without input from the operator thus reducing operator induced errors. It also measures the thickness of the entire optic nerve head so as to allow for another anatomic area of the eye to be measured for assessment of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data in three concentric circles instead of just one in order to account for different sizes of optic nerves.
Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye Center and its associated satellite clinics. Following informed consent, subjects undergo additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated satellite clinics. The imaging results may be used in clinical care for the subjects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Glaucoma arm Consecutive patients with glaucoma will undergo non-invasive OCT imaging |
Device: SDOCT-GMPE software
Noninvasive imaging of the optic nerve in patients with existing glaucoma
|
Outcome Measures
Primary Outcome Measures
- Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW) [imaging approximately 10 minutes]
Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
capable and willing to provide consent
-
history of clinically-diagnosed glaucoma
-
at least 18 years of age
Exclusion Criteria:
-
unable or unwilling to give consent
-
under 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Eye Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Sanjay Asrani, MD, Duke Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00056471
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Glaucoma Arm |
|---|---|
| Arm/Group Description | Consecutive patients with glaucoma will undergo non-invasive OCT imaging SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma |
| Period Title: Overall Study | |
| STARTED | 57 |
| COMPLETED | 55 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Glaucoma Arm |
|---|---|
| Arm/Group Description | 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 Participants | 55 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
59.5
(13.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
25
45.5%
|
| Male |
30
54.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
6
10.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
7
12.7%
|
| White |
39
70.9%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
5.5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
55
100%
|
Outcome Measures
| Title | Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW) |
|---|---|
| Description | Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW). |
| Time Frame | imaging approximately 10 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| All usable images of one eye of each participant |
| Arm/Group Title | Glaucoma Arm |
|---|---|
| Arm/Group Description | Consecutive patients with glaucoma will undergo non-invasive OCT imaging SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma |
| Measure Participants | 49 |
| Number [correlation coefficient] |
0.70
|
Adverse Events
| Time Frame | During measurement time (approximately ten minutes) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Glaucoma Arm | |
| Arm/Group Description | Consecutive willing patients with glaucoma will undergo non-invasive OCT imaging SDOCT-GMPE software: Noninvasive imaging of the optic nerve in patients with existing glaucoma | |
All Cause Mortality |
||
| Glaucoma Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Glaucoma Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Glaucoma Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/55 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sanjay Asrani |
|---|---|
| Organization | Duke University |
| Phone | 919-684-8656 |
| sanjay.asrani@duke.edu |
- Pro00056471