We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Computer Aided Evaluation of Orbital Volume

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584506
First Posted: January 2, 2008
Last Update Posted: December 20, 2010
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:
University of California, Davis
  Purpose
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
Orbital Fractures

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Computer Aided Evaluation of Orbital Volume

Further study details as provided by University of California, Davis:

Enrollment: 250
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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): NCT00584506


Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Edward B Strong, MD University of California, Davis
  More Information

Responsible Party: Edward B. Strong, MD, University of California Davis
ClinicalTrials.gov Identifier: NCT00584506     History of Changes
Other Study ID Numbers: 200715801-1
IORG: 0000251
First Submitted: December 26, 2007
First Posted: January 2, 2008
Last Update Posted: December 20, 2010
Last Verified: December 2010

Keywords provided by University of California, Davis:
orbital fractures

Additional relevant MeSH terms:
Orbital Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries