Clinical Trial: Tegaderm and Visual Evoked Potentials

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: A Pilot Study: Does Tegaderm Placement on Eyes to Prevent Lagophthalmos Affect Visual Evoked Potentials Data Latency and Amplitude

Brief Summary:

The purpose of this study is to determine if a clear barrier placed over the eyes has any effect on goggle monitoring. When a patient has general anesthesia they lose the ability to blink and their eyes may dry. They may also lose the ability to keep their eyes fully closed. The anesthesiologist takes several steps to prevent injury to the eyes. First the eyes will be lubricated with ointment and the eyelids will be held in a closed position by the use of a clear barrier. During pituitary surgery it is the routine practice to perform many types of monitoring. One type of monitoring is to stimulate your eyes with a light. This helps your surgeon protect the nerve supply to your eyes. The light is supplied by a pair of goggles placed over your eyes during surgery.

To help achieve our objective, the investigators are asking patients who are undergoing pituitary surgery to give us permission to record two sets of numbers form the monitoring device once prior to the application of the clear barrier and the second after the barrier is applied. This will be done when the patient is already asleep and will not be aware this is happening.

Detailed Summary:

Corneal injury is the most frequent ocular complication during general anesthesia as the patient does not have the ability to blink or keep their eyes completely closed. Lagophthalmos is defined as the inability to close the eyelids completely. Blinking covers the eye with a thin layer of tear fluid, thereby promoting a moist environment necessary for the cells of the exterior part of the eye. The tears also flush out foreign bodies and wash them away. This is crucial to maintain lubrication and proper eye health. If this process is impaired, as in lagophthalmos, the eye can suffer abrasions and infections. Lagophthalmos leads to corneal drying and ulceration. Several strategies are widely used to try and prevent corneal abrasions, although there is a paucity of recent studies to support one method over another. If a patient is to receive general anesthesia the common practice is to lubricate the eyes and tape them closed.

One of the ways to prevent lagophthalmos is to use tegaderm. A tegaderm is a thin transparent barrier customarily used to protect wounds and catheter sites. The tegaderm has several advantages including breathability and conformity to skin. In the operating room it is place over the patients' eyelids to keep the eyes closed and prevent injury.

During surgical removal of a pituitary adenoma, conduction in the anterior visual pathways is monitored by continuous recording of visual evoked potentials (VEP). The VEP tests the function of the visual pathway from the retina to the occipital cortex. It measures the conduction of the visual pathways from the optic nerve, optic chiasm, and optic radiations to the occipital cortex. This method is performed by the application of special goggles over the eyes. These goggles placed over the tegaderm are noninvasive and have an embedded flashing diode for delivery of v
Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome: change in latency of VEP [ Time Frame: 1 minute ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in amplitude of VEP [ Time Frame: 1 minute ]

Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: January 15, 2014
Date Started: July 2013
Date Completion:
Last Updated: March 10, 2015
Last Verified: September 2014