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Computer Aided Evaluation of Orbital Volume

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT00584506
Collaborator
(none)
250
Enrollment
32
Duration (Months)

Study Details

Study Description

Brief Summary

A retrospective review to assess the performance and clinical predictive value of a novel software program (Maxillo) designed to perform complex volumetric analysis with application in the field of orbital trauma.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The concept of open reduction and internal fixation of large and complex traumatic orbital deformities is well established. It is known that successful orbital reconstruction hinges upon restoration of native orbital volume in order to establish pre-morbid function and avoid long-term complications. To date, a facile, reliable, and reproducible method to measure orbital volume has not been rendered, despite numerous approaches. The objective of this study is to assess the performance and clinical predictive value of a novel software program designed to perform complex volumetric analysis with application in the field of orbital trauma.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Time Perspective:
    Retrospective
    Official Title:
    Computer Aided Evaluation of Orbital Volume
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Jul 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      3 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Chart reviews of patients at UCDMC with orbital trauma and having operative repair of the orbital fractures with post-reduction imaging included.
      Exclusion Criteria:
      • Absences of post-operative imaging

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • University of California, Davis

      Investigators

      • Principal Investigator: Edward B Strong, MD, University of California, Davis

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00584506
      Other Study ID Numbers:
      • 200715801-1
      • IORG: 0000251
      First Posted:
      Jan 2, 2008
      Last Update Posted:
      Dec 20, 2010
      Last Verified:
      Dec 1, 2010
      Keywords provided by , ,
      orbital fractures
      Additional relevant MeSH terms:
      Orbital Fractures

      Study Results

      No Results Posted as of Dec 20, 2010