SDOCT-GMPE Software

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: SDOCT-GMPE software

• Registration Number: NCT02235454
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-10
• Study Start: 2014-11
• Primary Completion: 2016-08-01
• Study Completion: 2016-08-01
• Status Verified: 2017-06
• Results First Submitted: 2017-06-26
• Results First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Results First Posted: 2017-07-26
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• capable and willing to provide consent
• history of clinically-diagnosed glaucoma
• at least 18 years of age

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Exclusion Criteria

• unable or unwilling to give consent
• under 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucoma arm	SDOCT-GMPE software	Consecutive patients with glaucoma will undergo non-invasive OCT imaging

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States