NCT03323307

Brief Summary

The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

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

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 5, 2019

Completed
Last Updated

December 5, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

October 24, 2017

Results QC Date

November 12, 2019

Last Update Submit

November 12, 2019

Conditions

Optical Coherence Tomography (OCT) of the Retina

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Acceptable OCT Image Quality

    measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device

    day 1

Secondary Outcomes (2)

  • Central Macular Thickness

    day 1

  • Total Macular Volume

    day 1

Study Arms (1)

OCT imaging

EXPERIMENTAL

OCT device images retina

Device: OCT imaging

Interventions

OCT imagingDEVICE

imaging of retina using OCT device

OCT imaging

Eligibility Criteria

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

You may qualify if:

  • patients scheduled to receive standard OCT testing as part of their clinical visit

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Urea Cycle Disorders, InbornBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

Acquiring data for the secondary endpoints was not feasible given the technical limitations of the current low cost OCT system set up.

Results Point of Contact

Title
Dr. Adam Wax
Organization
Duke University
a.wax@duke.edu
919-660-5143

Study Officials

  • Adam Wax, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

March 28, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

December 5, 2019

Results First Posted

December 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)