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Assessment of a New Goldmann Applanation Tonometer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555763
First Posted: November 9, 2007
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Haag-Streit AG
Information provided by:
University Hospital Inselspital, Berne
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 ]

Enrollment: 157
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555763


Locations
Switzerland
University Eye Hospital Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Haag-Streit AG
Investigators
Principal Investigator: Milko E Iliev, MD University Eye Hospital Berne
Study Director: Sebastian Wolf, MD University Eye Hospital Berne
  More Information

Publications:
Responsible Party: Milko Iliev, MD, University Hospital Inselspital; Berne
ClinicalTrials.gov Identifier: NCT00555763     History of Changes
Other Study ID Numbers: 1410
162/07
First Submitted: November 8, 2007
First Posted: November 9, 2007
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by University Hospital Inselspital, Berne:
Intraocular pressure
Goldmann tonometry
applanation tonometry
Tonometry, Ocular