Back to resultsSDOCT-GMPE Software
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SDOCT-GMPE software
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring glaucoma, OCT, spectral domain optical coherence tomography
Eligibility 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
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Glaucoma arm
Arm Description
Consecutive patients with glaucoma will undergo non-invasive OCT imaging
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02235454
Brief Title
SDOCT-GMPE Software
Official Title
A Prospective Evaluation of the Novel Glaucoma Premium Edition Software for Spectral Domain Optical Coherence Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, OCT, spectral domain optical coherence tomography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma arm
Arm Type
Other
Arm Description
Consecutive patients with glaucoma will undergo non-invasive OCT imaging
Intervention Type
Device
Intervention Name(s)
SDOCT-GMPE software
Intervention Description
Noninvasive imaging of the optic nerve in patients with existing glaucoma
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Asrani, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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