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NCT02235454 Clinical Trial

SDOCT-GMPE Software

Glaucoma Clinical Trial

Official title:
A Prospective Evaluation of the Novel Glaucoma Premium Edition Software for Spectral Domain Optical Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02235454
Other study ID # Pro00056471
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2014
Last updated December 5, 2016
Start date November 2014
Est. completion date November 2018

Study information
Verified date December 2016
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date November 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• SDOCT-GMPE software
Noninvasive imaging of the optic nerve in patients with existing glaucoma

Locations
Country Name City State
United States Duke Eye Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary RNFL thickness day of imaging approximately 1 hour No
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