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Evaluation of RTVue in Corneal Measurement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220193
First Posted: October 13, 2010
Last Update Posted: February 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Optovue
  Purpose
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.

Condition
Normal Cornea Post Laser Refractive Surgery Cornea Pathology Cataract Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of RTVue in Corneal Measurement

Further study details as provided by Optovue:

Estimated Enrollment: 196
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal cornea
Post laser refractive surgery
Cornea pathology
Cataract surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Various ocular conditions to include normal, pathology, post refractive surgery and cataract.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220193


Locations
United States, California
Gordon Binder & Weiss Vision Institute
San Diego, California, United States, 92122
United States, New York
Brass Eye Center
Latham, New York, United States, 12110
Sponsors and Collaborators
Optovue
  More Information

Responsible Party: Qienyuan Zhou, PhD, Optovue
ClinicalTrials.gov Identifier: NCT01220193     History of Changes
Other Study ID Numbers: RTVue 100 - 2009
First Submitted: October 11, 2010
First Posted: October 13, 2010
Last Update Posted: February 18, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Cataract
Corneal Diseases
Lens Diseases
Eye Diseases