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Evaluation of RTVue in Corneal Measurement

Sponsor
Optovue (Industry)
Overall Status
Completed
CT.gov ID
NCT01220193
Collaborator
(none)
196
Enrollment
2
Locations
20
Duration (Months)
98
Patients Per Site
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    196 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of RTVue in Corneal Measurement
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Normal cornea
    Post laser refractive surgery
    Cornea pathology
    Cataract surgery

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Gordon Binder & Weiss Vision Institute San Diego California United States 92122
      2 Brass Eye Center Latham New York United States 12110

      Sponsors and Collaborators

      • Optovue

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01220193
      Other Study ID Numbers:
      • RTVue 100 - 2009
      First Posted:
      Oct 13, 2010
      Last Update Posted:
      Feb 18, 2011
      Last Verified:
      Feb 1, 2011
      Additional relevant MeSH terms:
      Cataract
      Corneal Diseases

      Study Results

      No Results Posted as of Feb 18, 2011