Assessment of a New Goldmann Applanation Tonometer - Full Text View

Sponsors and Collaborators:	University Hospital Inselspital, Berne Haag-Streit AG Switzerland
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00555763

Purpose

The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.

The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.

Condition	Intervention	Phase
Intraocular Pressure	Device: Tonometry	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Assessment of a New Goldmann Applanation Tonometer

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Intraocular Pressure in mmHG [ Time Frame: single event ]

Secondary Outcome Measures:

safety of measurement [ Time Frame: single event, up to one week post measurement ]

Estimated Enrollment:	150
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Active Comparator	Device: Tonometry Tonometry : measurement of intraocular pressure with an applanation tonometer

Detailed Description:

The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.

The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.

Patients at the Department of Ophthalmology, University of Bern, will be included after informed consent. The study has been approved by the local ethical committee. Routine ophthalmologic examination will be performed and inclusion criteria evaluated. Measurements will be taken with the two tonometers in random order. Prior to pressure measurement, central corneal thickness will be measured with a non-contact method (Optical Low Coherence Reflectometry, OLCR pachymeter, Haag-Streit, Koeniz, Switzerland).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

patient willing to participate and signed informed consent

Exclusion Criteria:

patient under 18 y of age
patient pregnant
not steady fixation, nystagm
corneal scars or corneal disease
astigmatism higher than 2.5 diopters
corneal surgery in the past
microphthalmos or buphthalmos
contact lens wear
dry eye syndrome
blepharospasm
active inflammation of conjunctiva, cornea or uvea
known allergy to topical oxybuprocain for topical anaesthesia
known allergy to fluorescein solution (used for applanation tonometry)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555763

Contacts

Contact: Milko E Iliev, MD

+41 31 632 2111

milko.iliev@insel.ch

Locations

Switzerland
University Eye Hospital Berne	Recruiting
Berne, Switzerland, 3010
Principal Investigator: Milko E Iliev, MD
Sub-Investigator: Anna Kipfer, MD
Sub-Investigator: Kaspar Rohrer, MD
Sub-Investigator: Christoph Tappeiner, MD
Sub-Investigator: David Goldblum, MD
Sub-Investigator: Matthias Egli

Sponsors and Collaborators

University Hospital Inselspital, Berne

Haag-Streit AG Switzerland

Investigators

Principal Investigator:	Milko E Iliev, MD	University Eye Hospital Berne
Study Director:	Sebastian Wolf, MD	University Eye Hospital Berne

More Information

Publications:

SCHMIDT TA. The clinical application of the Goldmann applanation tonometer. Am J Ophthalmol. 1960 May;49:967-78. No abstract available.

GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry.] Ophthalmologica. 1961 Jun;141:441-56. German. No abstract available.

GOLDMANN H, SCHMIDT T. [Applanation tonometry.] Ophthalmologica. 1957 Oct;134(4):221-42. German. No abstract available.

Study ID Numbers:	1410, 1410
Study First Received:	November 8, 2007
Last Updated:	November 23, 2007
ClinicalTrials.gov Identifier:	NCT00555763
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:

Intraocular pressure
Goldmann tonometry
applanation tonometry
Tonometry, Ocular

ClinicalTrials.gov processed this record on January 15, 2009