Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01254149 |
| Other study ID # |
0577-10-FB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 17, 2011 |
| Est. completion date |
April 1, 2012 |
Study information
| Verified date |
August 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary purpose of this study is to determine whether topical ophthalmic anesthetics
lower the intraocular pressure in the eye.
Description:
Each day almost all patients in an ophthalmology clinic get their intraocular pressure of
each eye measured. This measurement is used to make important decisions regarding risk of
dilation and also is essential in the management of glaucoma patients, as intraocular
pressure (IOP) remains one of the only modifiable factors in glaucoma. The intraocular
pressure is also measured in an eye that has undergone an operative procedure where pressures
can increase to dangerous levels signaling the need for immediate intervention.
In most ophthalmology clinics the intraocular pressure is measured via Goldmann applanation
tonometry, which is considered the standard method of measurement. The Goldmann tonometer is
a device that uses an applanation prism to flatten a small portion of the cornea to measure
the eye. The pressure within the eye is determined by how much force is needed to flatten the
cornea. In order to perform the test the subject receives a topical anesthetic and
fluorescein sodium dye on the surface of the eye. The intraocular pressure is all frequently
measured in ophthalmology by pneumatonometry and the Tonopen. These two additional methods of
contact tonometry measure the amount of force needed to displace the cornea and then
calculate the intraocular pressure1. Both require instillation of topical anesthetic eye
drops prior to measuring the pressure, cut these latter two methods require no dye. The
principal anesthetics used in the United States are proparacaine or benoxinate. For Goldmann
applanation, these anesthetics must be combined with a fluorescein dye.
Both proparacaine and benoxinate are esters of para-aminobenzoic acid (PABA) that are used
for topical ophthalmic anesthesia. Both have onset of action in approximately 10-20 seconds
and both duration of action of 10-20 minutes. They provide sufficient anesthesia to permit
minor procedures involving the superficial cornea and conjunctiva. Proparacaine is commonly
used alone, but can be purchased pre-mixed with fluorescein dye, whereas, benoxinate is only
available in combination with fluorescein dye1. Fluorescein sodium is a yellow acid dye from
the xanthenes family that absorbs light of the 493 nanometer wavelength (blue) and then emits
or fluoresces light of 520 nanometer wavelength (yellow-green). This dye is ubiquitous in
ophthalmologic practices as it is used both intravenously and topically to assist in making
ophthalmologic diagnoses1.
For contact tonometry, one of these topical anesthetics is traditionally instilled in each
eye and the intraocular pressure is then measured. This is typically done by a technician
first, and if there is any question regarding the measurement it is repeated again by the
physician seeing the patient. In academic institutions the intraocular pressure may also be
routinely checked additional times by the resident. For certain patients suspected of having
glaucoma the intraocular pressure variation throughout the day is monitored in what is called
a diurnal curve measurement. With this test, the intraocular pressure may be checked upwards
of ten (10) times in a single day (each measurement with an additional instillation of
topical anesthetic). All of these examinations are done with minimal danger and with little
discomfort for the patient.
Despite this standard protocol for measurement of the intraocular pressure, it has been
suggested that the very anesthetic agents we use to measure the pressure may actually cause
some lowering of the intraocular pressure. In rabbits proparacaine has recently been shown to
reduce episcleral venous pressure, an important component of the intraocular pressure, and
the intraocular pressure itself (Zamora). Attempts to show the pressure lowering effect of
these frequently used topical anesthetics in humans using our traditional intraocular
measurement devices has been difficult as all three methods mentioned above require topical
anesthetic. Some European studies have used non-contact tonometry to verify these findings.
For example, Montero et al used non-contact tonometry to determine the effect of the topical
anesthetics and found that there was a statistically significant decrease in the intraocular
pressure after application of topical anesthetic3. Baudouin et al also found that, when
measured via non-contact tonometry, some topical anesthetics lower the intraocular pressure4.
In their study the topical anesthetics, oxybuprocaine and betoxycaine used more frequently in
the United States. Both of these studies were done using non-contact tonometry. Traditionally
with non-contact tonometry, a puff of air is directed towards the corneal surface and the
displacement of the corneal surface is measured and used to estimate the intraocular
pressure. However, in the United States most ophthalmology offices rely on contact tonometry
to evaluate the intraocular pressure rather than non-contact tonometry. Based on our review
of the literature, no one has yet measured the intraocular pressure lowering effects of these
topical anesthetics with contact tonometry.
There is a currently a device on the market which is approved by the Food and Drug
Administration that is able to measure intraocular pressure via contact tonometry that does
not require use of topical anesthetic drops. This device is sold as the ICare tonometer. The
ICare is a tonometer that uses a rebound technology in which a very light-weight probe is
used to make momentary contact with the cornea. In rebound technology, the motion parameters
of the probe are recorded during the measurement. An induction based coil system and advanced
algorithms analyze the probe deceleration, contact time and other parameters as the probe
touches the cornea. The deceleration and rebound parameters change as a function of the
intraocular pressure. The tonometer is preprogrammed for six measurements, discarding the
highest and lowest intraocular pressure readings, and calculating the average pressure value.
The pressure is recorded in millimeters of mercury (mmHg). No anesthesia is involved because
the touch of the probe is so gentle that intraocular pressure measurement is barely noticed
by the subject5. The ICare is currently used on patients in our clinic for whom the
traditional intraocular pressure measurement devices have not been appropriate like newborns
and infants. It does not require topical anesthesia and recent data supports that its
intraocular pressure measurements are reliable6,7. Thus, the ICare tonometer finally provides
a way to use contact tonometry to verify whether or not the two most commonly used topical
anesthetics lower intraocular pressure.
