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Normal Tension GlaucomaNCT01254149

IOP Lowering Effects of Topical Anesthetics Used Frequently in the Ophthalmology Clinic

An observational study of Normal Tension Glaucoma, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to determine whether topical ophthalmic anesthetics lower the intraocular pressure in the eye. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Normal Tension Glaucoma
How many people
43 participants
Where
1 siteUnited States
Study dates
17 Jan 2011to 1 Apr 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects 19 years of age and older with normal eyes and with ocular disease.

Who may be able to join

  • Subjects must be 19 years of age and older

Who cannot join

  • Corneal diseases including corneal transplants, corneal dystrophies, or trauma to the cornea that may prevent reliable tonometry of either eye.
  • Intolerant to topical Proparacaine and Benoxinate
  • Pregnant or nursing
  • 18 years of age and younger.
  • Physical limitation preventing ability to obtain reliable intraocular measurements (e.g. difficulty positioning subjects in front of the slit lamp or inability to keep eyes open during the intraocular pressure checks).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska Medical Center, Department of Ophthalmology

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Intraocular Pressure Lowering Effects of Topical Anesthetics Used Frequently in the Ophthalmology Clinic

The primary purpose of this study is to determine whether topical ophthalmic anesthetics lower the intraocular pressure in the eye.

Read the detailed 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.

Medical subject headings
Low Tension Glaucoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measured pressures in subjects' eyes with and without anesthetics.

    Intraocular pressure is measured via Goldmann applanation tonometry, which is considered the standard method of measurement with and without anesthetics.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2010 (estimated)
  2. Study start17 Jan 2011
  3. Primary completion1 Apr 2012
  4. Study completion1 Apr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254149
Sponsor's protocol ID
0577-10-FB
Status last verified
Aug 2023
First submitted
2 Dec 2010
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Normal Tension Glaucoma, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measured pressures in subjects' eyes with and without anesthetics. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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