Determine the Effect of Intraocular Pressure (IOP), Optic Nerve Imaging, Venous Congestion in Volunteers Prone Position 5 Hours

This study has been completed.
Sponsor:
Collaborator:
Anesthesia Patient Safety Foundation
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00875043
First received: April 1, 2009
Last updated: April 2, 2009
Last verified: April 2009

April 1, 2009
April 2, 2009
March 2008
June 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00875043 on ClinicalTrials.gov Archive Site
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Determine the Effect of Intraocular Pressure (IOP), Optic Nerve Imaging, Venous Congestion in Volunteers Prone Position 5 Hours
A Pilot Study to Determine the Effect on Intraocular Pressure, Optic Nerve Imaging and Other Markers of Venous Congestion of Volunteer Subjects in the Prone Position for a Period of Five Hours

The purpose of this study is to provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. An improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss.

Post operative vision loss resulting from nonocular surgery is a devastating, poorly understood and potentially preventable complication. Ischemic optic neuropathy, affecting both the anterior or posterioir portions of the optic nerve, is the most common cause of postoperative vision loss(POVL). Other, less common causes include retinal artery occlusion, retinal vein occlusion, retinal embolism, and cortical blindness. The estimated incidence of POVL in patients undergoing general anesthesia is 1/60,000. The incidence dramatically increases in cardiopulmonary bypass and prone spine surgery with estimates at 1/1600 and 1/1100, respectively. The etiology is unknown but it is thought to be multifactorial, and several potential risk factors have been identified, including degree of hypotension, preoperative hematocrit, external compression of the eye, blood loss and prone position. The investigators are proposing eight volunteers in two different sessions of 5.5 hours each. The first session the volunteer will lie prone of the flat Jackson table and the second session the volunteer will spend 5 hours prone on the Jackson table with a table elevation of 6 inches. The following measurements will be done: Intraocular Pressure (IOP) with a device called the Tonopen-XL, the Nidex NM 200 to visualize the retinal optic nerve imaging, refractometry, ultrasound, corneal thickness pachymetry, measurement of proptosis, measurement of pupillary reflex, The volunteers do not receive anesthetic medications or intravenous fluids and will provide a baseline for comparision with patients enrolled in the prospective study.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

Healthy volunteers

Blindness
Not Provided
  • 1. flat Jackson table
    All measurements previously described will be done with the patient in the prone postion and Jackson table flat.
  • 2. Elevated Jackson tablet
    All measurements previously described will be performed with subjects placed prone on the elevated Jackson table.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • subjects willing to consent

Exclusion Criteria:

  • individuals unable to tolerate prone position for 5 hours
  • individuals unable to tolerate contact lens placement
  • females who are pregnant
  • individuals with a sensitivity to proparacaine hcl 0.5% or tropicamide 1%
  • individuals who are unable to have repeated mesaurements of intaocular pressure
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00875043
0120070324
No
Geordie P. Grant, MD, UMDNJ
University of Medicine and Dentistry New Jersey
Anesthesia Patient Safety Foundation
Principal Investigator: Geordie P. Grant, MD University of Medicine & Dentistry of New Jersey
University of Medicine and Dentistry New Jersey
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP