Computer Aided Evaluation of Orbital Volume

December 16, 2010 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

250

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

3 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with complex maxillofacial and orbital trauma that underwent operative repair of orbital fractures. Computer tomography scans from a cohort of patients with normal CT data sets will also be collected to assess "normative" orbital volumes.

Description

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

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

  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

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

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

November 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

December 20, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200715801-1
  • IORG: 0000251

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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