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Trial record 4 of 18 for:    PREMIUM

SDOCT-GMPE Software

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02235454
First received: September 5, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Glaucoma
Device: SDOCT-GMPE software

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • RNFL thickness [ Time Frame: day of imaging approximately 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
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)
Arms Assigned Interventions
Glaucoma arm
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02235454

Locations
United States, North Carolina
Duke Eye Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Sanjay Asrani, MD    919-684-2841    sanjay.asrani@duke.edu   
Contact: Garrick Chak, MD    919-684-2841    garrick.chak@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Sanjay Asrani, MD Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02235454     History of Changes
Other Study ID Numbers: Pro00056471
Study First Received: September 5, 2014
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
glaucoma
OCT
spectral domain optical coherence tomography

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014