Low Cost OCT for Point of Care

NCT ID: NCT03323307

Last Updated: 2019-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2018-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Optical Coherence Tomography (OCT) of the Retina

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OCT imaging

OCT device images retina

Group Type EXPERIMENTAL

OCT imaging

Intervention Type DEVICE

imaging of retina using OCT device

Interventions

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OCT imaging

imaging of retina using OCT device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Wallace H. Coulter Foundation

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Wax, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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University of North Carolina Kittner Eye Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00087122

Identifier Type: -

Identifier Source: org_study_id

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