Intraocular Pressure During Prone Spinal Surgery

NCT00176722 | Terminated

• 1 other identifier: 0120040320
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spine Surgery; Vision Impairment

Keywords

Spine Surgery; Intraocular Pressure; lumbar or thoracic Spine Surgery in the prone position; and its association with visual change

Outcome Measures

Primary Outcomes (1)

• changes in intraocular pressure and retinal oximetry

  over introperative time

Study Arms (1)

surgical

males \& females undergoing spine surgery in the prone position

Other: table tilt

Interventions

table tilt OTHER

One group randomized to table tilt. One group will be flat.

surgical

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects undergoing spine surgery in the prone position.

You may qualify if:

• Men and women between the ages of 18 and 65 years of age who are mentally capable of providing an informed consent.
• Planned elective spinal surgery in which the modified Jackson table will be used.

You may not qualify if:

• Failure to provide an informed consent
• History of stroke
• Known history of corneal disease
• Known history of carotid disease
• Known history of sensitivity to cyclogyl and/or proparacaine HCL 0.5%

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Foundation for Anesthesia Education and Research: collaborator
• New Jersey Eye Institute: collaborator

Study Sites (2)

University of Medicine & Dentistry - New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

University of Medicine & Dentistry of NJ

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geordie Grant, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

US (2)