Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02105337 |
| Other study ID # |
2013002781 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
January 15, 2014 |
| Last updated |
March 10, 2015 |
| Start date |
July 2013 |
| Est. completion date |
September 2014 |
Study information
| Verified date |
September 2014 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug Administration |
| Study type |
Observational
|
Clinical Trial 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.
Description:
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 visual stimuli. Changes of the occipital EEG (as recorded
intraoperatively on a computer program by a neurophysiology technician) can be observed
under stimulation of light in attempt to localize structures or possible damage of those
structures in the primary visual pathway. This is helpful to the neurosurgeon who aims to
avoid compression and injury to the optic nerve.
These goggles have been used routinely over years for visual pathway monitoring during
pituitary tumor resection. Nevertheless there is a question if the application of tegaderm
affects VEP monitoring. By measuring visual evoked potentials before and after tegaderm
placement, we hope to determine if there is a change in evoked potential data due to
placement of tegaderm. On other words, we will be able to identify if tegaderm placement
affects visual evoked potential data reliability.
Experimental Plan:
The investigators will approach all patients over the age of 18 undergoing transsphenoidal
pituitary tumor resection with visual evoke potential monitoring.The plan is to include 40
patients here at University Hospital. If patients are agreeable all subjects will have their
VEP measured before and after routine tegaderm application. Visual evoked potential
monitoring will be conducted as routinely done by the neurophysiology technician. Data will
be collected from neurophysiologist report and then analyzed for latency and amplitude
before and after tegaderm application. As a matter of routine, the full monitoring report
becomes a component of the patient's medical record.
