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OpenTrials
Completed

NCT Number: NCT02235454

SDOCT-GMPE Software

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDOCT-GMPE software

Device

Noninvasive imaging of the optic nerve in patients with existing glaucoma

Primary outcomes

  1. Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2014
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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