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Assessment of a New Goldmann Applanation Tonometer

This study has been completed.
Sponsor:
Collaborator:
Haag-Streit AG
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00555763
First received: November 8, 2007
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of measurement [ Time Frame: single event, up to one week post measurement ] [ Designated as safety issue: Yes ]

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

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

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
Study First Received: November 8, 2007
Last Updated: July 13, 2011
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 May 21, 2013