Evaluation of RTVue in Corneal Measurement

February 16, 2011 updated by: Optovue
The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

196

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
      • San Diego, California, United States, 92122
        • Gordon Binder & Weiss Vision Institute
    • New York
      • Latham, New York, United States, 12110
        • Brass Eye 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Various ocular conditions to include normal, pathology, post refractive surgery and cataract.

Description

Inclusion Criteria:

Normal cornea:

  • 18 years of age or older
  • No corneal pathology
  • No prior ocular surgery and no prior laser refractive surgery

Post laser refractive surgery:

  • 18 years of age or older
  • No corneal pathology
  • No prior ocular surgery except laser refractive surgery
  • At least 1 week post laser refractive surgery without complication

Corneal pathology:

  • 18 years of age or older
  • Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant)
  • No prior laser refractive surgery

Cataract surgery:

  • 18 years of age or older
  • No corneal pathology
  • No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery
  • Post surgery visit shall only include eyes without complication

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

Cohorts and Interventions

Group / Cohort
Normal cornea
Post laser refractive surgery
Cornea pathology
Cataract surgery

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

April 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTVue 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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