Clinical Validation Study of RTVue Features

June 9, 2011 updated by: Optovue
To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Study Overview

Status

Completed

Conditions

Detailed Description

Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

Study Type

Observational

Enrollment (Actual)

53

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

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

Volunteers with various ocular pathology or no ocular pathology

Description

Inclusion Criteria:

  • Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
  • Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
  • Retina patients will have clinical exam results consistent with retina pathology.

Exclusion Criteria:

  • Normal subjects will be free of any ocular pathology.
  • Glaucoma patients will be free of any ocular pathology except glaucoma.
  • Retina patients will be free of any ocular pathology except any type of 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 the clinical exam and free of ocular pathology.
Glaucoma
Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
Retina
Clinical exam results consistent with retina pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retina measurement
Time Frame: at time of study visit (day 1)
at time of study visit (day 1)

Collaborators and Investigators

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

Sponsor

Optovue

Investigators

  • Study Director: Mike 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

March 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTVue Validation Study

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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