Intraocular Pressure Lowering Effects of Topical Anesthetics Used Frequently in the Ophthalmology Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Measured pressures in subjects' eyes with and without anesthetics.
研究概览
简要总结
The primary purpose of this study is to determine whether topical ophthalmic anesthetics lower the intraocular pressure in the eye.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 19 years of age and older
排除标准
- •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).
结局指标
主要结局
Measured pressures in subjects' eyes with and without anesthetics.
时间窗: 30 minutes
Intraocular pressure is measured via Goldmann applanation tonometry, which is considered the standard method of measurement with and without anesthetics.
次要结局
未报告次要终点
