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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma arm | Other | Consecutive patients with glaucoma will undergo non-invasive OCT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDOCT-GMPE software | Device | Noninvasive imaging of the optic nerve in patients with existing glaucoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW) | Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW). | imaging approximately 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Asrani, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW) | Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW). | All usable images of one eye of each participant | Posted | Number | correlation coefficient | imaging approximately 10 minutes |
|
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During measurement time (approximately ten minutes)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glaucoma Arm | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Asrani | Duke University | 919-684-8656 | sanjay.asrani@duke.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
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| 0 |
| 55 |
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| 55 |
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