Intraocular PressureCCTNCT00570791
Effect of Central Corneal Thickness On IOP Using Various Tonometers
An observational study of Intraocular Pressure, run by University of Nebraska at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Tonometer
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2005to 1 Nov 2011
- 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: Clinic Patients, City Residents
Who may be able to join
- Age > 19.
- Patients may or may not be on IOP lowering medication.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska Medical Center, Department of Ophthalmolgy and Visual Sciences
Omaha, Nebraska, 68198-5540
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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
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.
Read the 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.
- Conditions
- Intraocular Pressure
- Being tested
- Tonometer
- Keywords
- Cornea, Tonometers, Goldmann applanation, Tonopen, Shiotz, Pneumatonometer
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonometerDevice
Tonometer devices used to measure IOP: Pascal Dynamic Contour Tonometer, Goldman Applanation Tonometer, Tono Pen, Reichart pneumatonometer, Langham Ocular Blood Flow, Schiotz Tonometer and ICare tonometer
| Study group | Role | What they receive |
|---|---|---|
| Effect of age on intraocular pressure | Correlation between age and IOP with GAT compared to other tonometers. Receives: Device: Tonometer | |
| Effect of CCT and IOP | Correlation between CCT and IOP among all tonometers Receives: Device: Tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye pressure
Measured pressure in participants' eyes with six different tonometers
Measured: one - two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study start29 Jun 2005
- Primary completion1 Nov 2011
- Study completion1 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol B Toris, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570791
- Sponsor's protocol ID
- 0441-04-FB
- Acronym
- CCT
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2007
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00570791
- Acronym / sponsor ID
- CCT / 0441-04-FB
- Conditions
- Intraocular Pressure
- Keywords
- Cornea, Tonometers, Goldmann applanation, Tonopen, Shiotz, Pneumatonometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 29 Jun 2005 (actual)
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Nov 2011 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of age on intraocular pressure | – | Device: TonometerCorrelation between age and IOP with GAT compared to other tonometers. |
| Effect of CCT and IOP | – | Device: TonometerCorrelation between CCT and IOP among all tonometers |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic Patients, City Residents
Key inclusion criteria (2 listed)
- Age > 19.
- Patients may or may not be on IOP lowering medication.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonometerTonometer devices used to measure IOP: Pascal Dynamic Contour Tonometer, Goldman Applanation Tonometer, Tono Pen, Reichart pneumatonometer, Langham Ocular Blood Flow, Schiotz Tonometer and ICare tonometer | Device | Effect of CCT and IOP, Effect of age on intraocular pressure |
Primary outcome
Eye pressure
Time frame: one - two hours
Measured pressure in participants' eyes with six different tonometers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol B Toris, PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure, run by University of Nebraska at 2 sites 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 2 inclusion and 9 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Eye pressure (time frame: one - two hours). 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 23 Sep 2024.