Clinical trial NCT00570791: Effect of Central Corneal Thickness On IOP Using Various Tonometers
Official title: The Effect of Central Corneal Thickness On Intraocular Pressure Measurements With the Goldman Applanation Tonometer, Ocular Blood Flow Pneumatonometer,Tono Pen,Pascal Dynamic Contour Tonometer, and Schiotz Tonometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Keywords: Cornea
Tonometers
Goldmann applanation
Tonopen
Shiotz
Pneumatonometer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-11
Enrollment: 166
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic Patients, City Residents

Brief summary: The primary purpose of this study is to evaluate the effects of ocular physical properties on intraocular pressure (IOP) measurements in eyes with healthy corneas using the following instruments to measure IOP: Goldmann applanation tonometer, pneumotonometer, ocular blood flow pneumotonometer, Tono-Pen, Pascal Dynamic Contour Tonometer and the Schiotz Tonometer. Ocular physical properties to be evaluated are:varying (CCT), corneal curvature (CC), axial length, anterior chamber depth and scleral rigidity. The secondary purpose of this is to determine if there is a correlation between CCT and other ocular properties, and which instruments that measure these other ocular properties are most affected by CCT.

Detailed description: Accurate estimation of intraocular pressure is an essential aspect in the diagnosis and management of glaucomatous eye disease. Glaucoma is a progressive optic neuropathy and a leading cause of blindness in the United States. In glaucoma, vision is lost through apoptosis (programmed cell death) of retinal ganglion cells, a type of cell in the retina that transmits visual information to the brain. Diagnosis of glaucoma is usually based on a combination of progressive, characteristic vision loss (measured using visual field testing) and progressive optic nerve head damage (as detected through dilated fundus examinations or disc photography). While a high pressure inside the eye (ocular hypertension, OHT) is not sufficient for a diagnosis of glaucoma, it is the greatest single risk factor for disease onset.

For decades, the gold standard for intraocular pressure measurement has been the Goldmann applanation tonometer. The Goldmann tonometer is calibrated based on a central corneal thickness of 500 micrometers. But, it is known that CCT varies between individuals and even between individual eyes. The various central corneal thicknesses (CCT)s are thought to influence the accuracy of IOP measurements and thus the diagnosis, screening, and treatment of patients with glaucoma. A study performed by Copt (1999) showed that ocular hypertensive patients have relatively thick corneas and normal tension glaucoma patients have relatively thin corneas. Thus it is thought that a thicker cornea creates falsely high IOP readings and a thinner cornea creates falsely low IOP readings. This was followed by a study performed by Lleo et al (2003) which showed that applanation tonometry and CCT positively correlated in normal eyes. More recently the following studies have also found a positive correlation between CCT and tonometry: Lui et al (2005), Tonnu et all (2005), Pourjavan et al (2005), Doyle et al (2005), Gunvant et al (2005), Brunsini et al (2005) and Rask et al (2005).

To further evaluate the effect of CCT on IOP measurement, the method and instruments used to measure IOP were compared. In a clinical setting IOP's are measured by four instruments, Goldmann applanation tonometer, ocular blood flow pneumatonometer, pneumatonometer or Tono-Pen. Singh et al (2001) concluded that the effect of central corneal thickness on Goldmann applanation tonometry accuracy appears not to be clinically relevant. However, Bhan et al (2002) showed that in eyes with normal corneas, the ocular blood flow pneumatonometer appears to be more affected by variation in CCT than the Goldmann tonometer, and the Tono-Pen is least affected by CCT. A limitation of this study is that corneal curvature (a measure of astigmatism) was not performed prior to measuring IOP. High amounts of astigmatism can impact IOP readings obtained from the Goldmann tonometer.

The PASCAL Dynamic Contour Tonometer is a new digital tonometer that provides a direct trans-corneal measurement of IOP and is sensitive enough to detect the ocular pulse amplitude (OPA) due to the patient's heartbeat. Supposedly, when using the principle of contour matching instead of applanation, the PASCAL eliminates the systematic errors inherent in all previous tonometers, such as the influence of corneal thickness and rigidity. Ku et al (2005) demonstrated that the Pascal tonometer was effective in reducing corneal thickness bias during IOP measurements.

It has long been thought that there is a significant positive correlation of scleral rigidity to IOP, thus with increasing pressure in the eye, a resulting increase in rigidity is noted. (1960). A study completed by Pallikaris et al. (2005) investigated a possible correlation of rigidity to other ocular found no correlation between the two.

The effect of CCT on IOP measurement is a clinical concern as erroneous IOP measurements may lead to misdiagnosis. The purpose of this study is to evaluate whether IOP measurements by Goldmann applanation, pneumotonometryocular blood flow pneumotonometry, y, Tono-Pen and the PASCAL Dynamic Contour Tonometer are affected by central corneal thickness, and if so, to what extent.

Eligibility criteria: Inclusion Criteria:

* Age \> 19.
* Patients may or may not be on IOP lowering medication.

Exclusion Criteria:

* History of baseline corneal disease including but not limited to: Fuchs' Dystrophy, Keratoconus, Iridocorneal Endothelial Syndrome, Lattice Dystrophy, Map-Dot- Fingerprint Dystrophy, or a history of Stevens-Johnson Syndrome.
* Wears hard or rigid contact lenses.
* History of inflammatory eye disease.
* History of ocular trauma within the past 6 months.
* History of ocular infection within the last 3 months.
* Any abnormality preventing reliable IOP readings.
* Subject has demonstrated potential for non-compliance with the study protocol (e.g. dosing schedule, visit schedule, or study procedures).
* History of severe hypersensitivity to topical fluorescein.
* Pregnant or breast feeding women.

Primary outcomes:
measure: Eye pressure
timeFrame: one - two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Department of Ophthalmolgy and Visual Sciences
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Carol B Toris, PhD
role: PRINCIPAL_INVESTIGATOR
References: