NCT02235454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 26, 2017

Completed
Last Updated

July 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

September 5, 2014

Results QC Date

June 26, 2017

Last Update Submit

June 26, 2017

Conditions

Glaucoma

Keywords

glaucomaOCTspectral domain optical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • 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).

    imaging approximately 10 minutes

Study Arms (1)

Glaucoma arm

OTHER

Consecutive patients with glaucoma will undergo non-invasive OCT imaging

Device: SDOCT-GMPE software

Interventions

SDOCT-GMPE softwareDEVICE

Noninvasive imaging of the optic nerve in patients with existing glaucoma

Glaucoma arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Sanjay Asrani
Organization
Duke University
sanjay.asrani@duke.edu
919-684-8656

Study Officials

  • Sanjay Asrani, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 10, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 26, 2017

Results First Posted

July 26, 2017

Record last verified: 2017-06

Locations

US(1)