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Spine SurgeryNCT00176722

Intraocular Pressure During Prone Spinal Surgery

An observational study of Spine Surgery and Vision Impairment, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spine Surgery, Vision Impairment
What is being tested?
table tilt
How many people
7 participants
Where
2 sitesUnited States
Study dates
Jun 2006to Jan 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects undergoing spine surgery in the prone position.

Who may be able to join

  • 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.

Who cannot join

  • 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%

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Medicine & Dentistry - New Jersey Medical School

    Newark, New Jersey, 07101

  • University of Medicine & Dentistry of NJ

    Newark, New Jersey, 07101

Other trials in United States

About this study

Official title: The Effect of Table Position on Intraocular Pressure (IOP) and Ocular Perfusion Pressure (OPP) During Prone Spine Surgery

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.

Read the detailed description

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.

Being tested
table tilt
Keywords
Spine Surgery, Intraocular Pressure, lumbar or thoracic Spine Surgery in the prone position, and its association with visual change
Medical subject headings
Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • table tiltOther

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

Study groups in NCT00176722
Study groupRoleWhat they receive
surgicalmales \& females undergoing spine surgery in the prone position
Receives: Other: table tilt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in intraocular pressure and retinal oximetry

    Measured: over introperative time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJun 2006
  3. Primary completionOct 2011
  4. Study completionJan 2012

Why it stopped: Principal Investigator is leaving the UMDNJ

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00176722
Sponsor's protocol ID
0120040320
Status last verified
Apr 2015
First submitted
13 Sep 2005
Last updated
24 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Surgery and Vision Impairment, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Principal Investigator is leaving the UMDNJ). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in intraocular pressure and retinal oximetry (time frame: over introperative time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.

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