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

August 30, 2019 updated by: Optovue
Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • IOVS
    • Ohio
      • Marysville, Ohio, United States, 43040
        • AMA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Seeing eye doctor for routine care

Description

IInclusion 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glaucoma
diagnosis of glaucoma
Device: SD-OCT
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
Normal
no glaucoma or retinal pathology or corneal conditions
Device: SD-OCT
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
Device: SD-OCT
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
Device: SD-OCT
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limits of agreement
Time Frame: Day 1
estimation of the interval within which a proportion of the differences between measurements lie
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression Analysis
Time Frame: Day 1
statistical process for estimating the relationships among variables
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optovue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2019

Primary Completion (ACTUAL)

August 2, 2019

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (ACTUAL)

February 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 200-53769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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