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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT00875043
Collaborator
Anesthesia Patient Safety Foundation (Other)
10
1
4
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jul 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 65 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 UMDNJ/University Hospital Newark New Jersey United States 07101

      Sponsors and Collaborators

      • Rutgers, The State University of New Jersey
      • Anesthesia Patient Safety Foundation

      Investigators

      • Principal Investigator: Geordie P. Grant, MD, University of Medicine & Dentistry of New Jersey

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Rutgers, The State University of New Jersey
      ClinicalTrials.gov Identifier:
      NCT00875043
      Other Study ID Numbers:
      • 0120070324
      First Posted:
      Apr 3, 2009
      Last Update Posted:
      Oct 14, 2016
      Last Verified:
      Apr 1, 2009
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Keywords provided by Rutgers, The State University of New Jersey
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Oct 14, 2016