Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate

NCT ID: NCT03852485

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-29

Study Completion Date

2019-08-30

Brief Summary

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Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Detailed Description

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The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Conditions

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Normal Eyes and Eyes With Ocular Pathologies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

no glaucoma or retinal pathology or corneal conditions

SD-OCT

Intervention Type DEVICE

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Glaucoma

diagnosis of glaucoma

SD-OCT

Intervention Type DEVICE

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Retina

diagnosis of AMD, DR or other retinal pathology

SD-OCT

Intervention Type DEVICE

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Cornea

wear contact lens or prior refractive surgery or having dry eye or KCN

SD-OCT

Intervention Type DEVICE

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Interventions

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SD-OCT

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
* Glaucoma - Have glaucoma and no history of other retinal pathology.
* Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
* Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria

* Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
* Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
* Retina - Unable to complete required exams.
* Cornea - Unable to complete required exams.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optovue

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IOVS

Newark, New Jersey, United States

Site Status

AMA

Marysville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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200-53769

Identifier Type: -

Identifier Source: org_study_id

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