Data Collection of OCT and OCTA-based Ocular Measurements

August 30, 2019 updated by: Optovue
Data Collection of OCT and OCTA-based Ocular Measurements

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.

Study Type

Observational

Enrollment (Actual)

482

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
    • California
      • Pomona, California, United States, 91766
        • Eye Care Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Eye Care Institute
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • IOVS
    • Ohio
      • Marysville, Ohio, United States, 43040
        • AMA Eye Physicians & Surgeons
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464
        • College of Optometry

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Persons having eyes without ocular pathology

Description

Inclusion Criteria:

  • No glaucoma
  • No retinal pathology
  • No systemic disorders impacting the eye
  • No ocular surgery or medical treatment of ocular condition

Exclusion Criteria:

  • High IOP
  • Poor vision
  • Clinical findings consistent with pathology
  • Unable to complete the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal thickness
Time Frame: Day 1
micrometers
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)

February 8, 2019

Primary Completion (Actual)

July 11, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 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

  • 200-53771

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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