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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Prospective Evaluation of the Novel Glaucoma Premium Edition Software for Spectral Domain Optical Coherence Tomography|
- RNFL thickness [ Time Frame: day of imaging approximately 1 hour ] [ Designated as safety issue: No ]
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02235454
|United States, North Carolina|
|Duke Eye Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Sanjay Asrani, MD 919-684-2841 email@example.com|
|Contact: Garrick Chak, MD 919-684-2841 firstname.lastname@example.org|
|Principal Investigator:||Sanjay Asrani, MD||Duke University Health System|