Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 8, 2007
July 13, 2011
August 2007
May 2008   (final data collection date for primary outcome measure)
Intraocular Pressure in mmHG [ Time Frame: single event ] [ Designated as safety issue: No ]
Intraocular Pressure in mmHG [ Time Frame: single event ]
Complete list of historical versions of study NCT00555763 on ClinicalTrials.gov Archive Site
safety of measurement [ Time Frame: single event, up to one week post measurement ] [ Designated as safety issue: Yes ]
safety of measurement [ Time Frame: single event, up to one week post measurement ]
Not Provided
Not Provided
 
Assessment of a New Goldmann Applanation Tonometer
Assessment of a New Goldmann Applanation Tonometer

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Intraocular Pressure
Device: Tonometry
Tonometry : measurement of intraocular pressure with an applanation tonometer
Active Comparator: 1
Intervention: Device: Tonometry

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
July 2008
May 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00555763
1410, 162/07
No
Milko Iliev, MD, University Hospital Inselspital; Berne
University Hospital Inselspital, Berne
Haag-Streit AG
Principal Investigator: Milko E Iliev, MD University Eye Hospital Berne
Study Director: Sebastian Wolf, MD University Eye Hospital Berne
University Hospital Inselspital, Berne
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP