Intraocular Pressure During Prone Spinal Surgery
|ClinicalTrials.gov Identifier: NCT00176722|
Recruitment Status : Terminated (Principal Investigator is leaving the UMDNJ)
First Posted : September 15, 2005
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Spine Surgery Vision Impairment||Other: table tilt||Phase 2|
Postoperative permanent visual loss is a rare but devastating complication of surgery estimated to occur after approximately 1/60,000 anesthetics. After procedures involving cardiopulmonary bypass and prone spinal surgery, the estimates are higher, 1/1600 to 1/1100, respectively and have led to the formation in July of 1999 of the Postoperative Visual Loss (POVL) Registry under the auspices of the American Society of Anesthesia (ASA) Committee on Professional Liability. The majority of reported cases as of early 2003 were associated with spine surgery (67%).
Of the spine cases, the majority were due to ischemic optic neuropathy (ION) (81%) followed by central retinal artery occlusion (13%) and unknown diagnosis (6%). Central retinal artery occlusion is characterized by periorbital edema, a cherry red spot at the fovea and monocular blindness. It is thought to be due to direct prolonged extraocular pressure on the globe and thus is preventable. Direct pressure on the eye is the etiology most often mentioned by spine surgeons in an attempt to explain all forms of postoperative visual loss.
Post anesthetic ION, affecting both the anterior and posterior portions of the optic nerve, however, is the more common diagnosis. The etiology is unclear but hypo perfusion of the optic nerve has been associated with multiple risk factors. The four patient factors are obesity, hypertension, diabetes and low preoperative hematocrit. There are five surgical factors, which include an operation of long duration, large blood loss, prone position, deliberate hypotension, and blood replacement strategies which increase the tissue fluid compartment while decreasing the hematocrit. ION occurs in patients who had their heads suspended in Mayfield tongs (18% of ION cases), virtually eliminating any source of external pressure. In addition, 58% of these patients had bilateral disease, making direct pressure less likely.
Thus, most POVL cases appear to be directly related to a change in retinal and/or optic nerve perfusion. The visual loss associated with anterior ION is caused by infarction in the watershed zones between the areas supplied by the posterior ciliary arteries, which are end arteries without anastomosis. Posterior optic neuropathy is thought to be caused by decreased oxygen delivery to the posterior portion of the optic nerve between the orbital apex and the entrance of the central retinal artery.
Critical to any discussion of perfusion to the eye is the concept of ocular perfusion pressure (OPP), defined as the difference between the mean arterial pressure (MAP) and the intraocular pressure (IOP). Unopposed decreases in MAP, increases in IOP or a combination of the two may result in hypo perfusion of the eye and can cause an ocular infarction at the level of the retina or optic nerve, leading to varying degrees of visual loss which is frequently bilateral and irreversible.
Animal data indicate that IOP increases with downward head tilting in the supine position, possibly due to increased episcleral venous pressure. Limited data for awake human volunteers indicate that IOP increases with supine positioning and is further elevated with head down tilting and prone positioning again possibly due to a rise in episcleral venous pressure.
This is a randomized prospective study examining the effect of the table position on intraocular pressure and ocular perfusion pressure during spine surgery.
Subjects will be recruited following the preoperative visit to the Neurosurgical office. An informed consent will be obtained after the consent for surgery is signed. A visual acuity exam will be performed with one of the study team members with the subject wearing corrective lenses on the morning of the surgery. The reactivity of the pupil will also be assessed via a penlight.
|Study Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||The Effect of Table Position on Intraocular Pressure (IOP) and Ocular Perfusion Pressure (OPP) During Prone Spine Surgery|
|Study Start Date :||June 2006|
|Primary Completion Date :||October 2011|
|Study Completion Date :||January 2012|
males & females undergoing spine surgery in the prone position
Other: table tilt
One group randomized to table tilt. One group will be flat.
- changes in intraocular pressure and retinal oximetry [ Time Frame: over introperative time ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176722
|United States, New Jersey|
|University of Medicine & Dentistry - New Jersey Medical School|
|Newark, New Jersey, United States, 07101|
|University of Medicine & Dentistry of NJ|
|Newark, New Jersey, United States, 07101|
|Principal Investigator:||Geordie Grant, MD||Rutgers, The State University of New Jersey|