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

NCT ID: NCT00875043

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-07-31

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.

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.

Conditions

Blindness

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

1. flat Jackson table

All measurements previously described will be done with the patient in the prone postion and Jackson table flat.

No interventions assigned to this group

2. Elevated Jackson tablet

All measurements previously described will be performed with subjects placed prone on the elevated Jackson table.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anesthesia Patient Safety Foundation

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geordie P. Grant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine & Dentistry of New Jersey

Locations

UMDNJ/University Hospital

Newark, New Jersey, United States

Countries

United States

Other Identifiers

0120070324

Identifier Type: -

Identifier Source: org_study_id