Clinical Validation Study for iVue

September 26, 2017 updated by: Optovue
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

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
      • Daly City, California, United States, 94015
        • Pacific Eye Specialists
    • Colorado
      • Denver, Colorado, United States, 80204
        • Colorado Retina Center

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Volunteers with various ocular pathology or no ocular pathology.

Description

Inclusion Criteria:

  • Normal: Normal results from clinical exam and free of ocular pathology.
  • Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
  • Cornea: Clinical exam results consistent with cornea pathology.
  • Retina: Clinical exam results consistent with retina pathology

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
Normal
Normal results from clinical exam and free of ocular pathology.
Glaucoma
Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
Retina
Clinical exam results consistent with retina pathology
Cornea
Clinical exam results consistent with cornea pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
thickness of ocular structures

Collaborators and Investigators

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

Sponsor

Optovue

Investigators

  • Principal Investigator: Michael Hee, MD, Pacific Eye Specialists
  • Principal Investigator: Nalin Mehta, MD, Colorado Retina Center
  • Study Director: Michael Sinai, PhD, 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

October 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

November 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • iVue 100-2009

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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