Sponsor study identifier
observational
7
1 country
2
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
January 2012
Actual (reported)Postoperative visual loss resulting from surgical procedures not performed on the eye is a devastating outcome for the patient and poorly understood by the medical community. It is potentially a preventable complication. Diminished blood supply to the optic nerve, affecting both the anterior or posterior portions of the optic nerve, is the most common cause of postoperative visual loss. Other, less common causes include occlusion of the retinal artery and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual loss increases in patients undergoing cardiopulmonary bypass and prone spinal surgery. Although the etiology of postoperative visual loss is unknown, it is thought to be multifactorial, and several potential risk factors have been identified, including degree of low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood loss, prolonged duration of surgical time and lying in the face down position. The investigators believe this study is a unique opportunity to examine the mechanisms responsible for the antecedents to postoperative visual loss (POVL) and ischemic optic neuropathy (ION), a devastating complication of (usually) an elective surgical procedure. The purpose of this research is to try and determine the potential variables responsible for postoperative visual loss which will assist the medical community in devising methods for its prevention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2005
Actual (reported)September 15, 2005
Actual (reported)June 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 2011
Actual (reported)January 2012
Actual (reported)changes in intraocular pressure and retinal oximetry
over introperative time
males \& females undergoing spine surgery in the prone position
One group randomized to table tilt. One group will be flat.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects undergoing spine surgery in the prone position.
University of Medicine & Dentistry - New Jersey Medical School
Newark, New Jersey, 07101, United States
University of Medicine & Dentistry of NJ
Newark, New Jersey, 07101, United States
Geordie Grant, MD
Rutgers, The State University of New Jersey
7 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Preoperative Prevention and Early Rehabilitation for Patients Undergoing Elective Spine Surgery
Contact the study team to confirm eligibility.
Primary Completion
October 2011
Actual (reported)Study Completion
January 2012
Actual (reported)Last Updated
April 24, 2015
Record last verified: 2015-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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