Evaluation of RTVue in Corneal Measurement

This study has been completed.
Sponsor:
Information provided by:
Optovue
ClinicalTrials.gov Identifier:
NCT01220193
First received: October 11, 2010
Last updated: February 16, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Qienyuan Zhou, PhD, Optovue
ClinicalTrials.gov Identifier: NCT01220193     History of Changes
Other Study ID Numbers: RTVue 100 - 2009
Study First Received: October 11, 2010
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014