Assessment of a New Goldmann Applanation Tonometer

Intraocular Pressure Clinical Trial

Official title:

Assessment of a New Goldmann Applanation Tonometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555763
• Other study ID #: 1410
• Secondary ID: 162/07
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2007
• Last updated: July 13, 2011
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• Tonometry
Tonometry : measurement of intraocular pressure with an applanation tonometer

Locations

Country	Name	City	State
Switzerland	University Eye Hospital Berne	Berne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Haag-Streit AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. German. — View Citation

GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. German. — View Citation

SCHMIDT TA. The clinical application of the Goldmann applanation tonometer. Am J Ophthalmol. 1960 May;49:967-78. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure in mmHG		single event	No
Secondary	safety of measurement		single event, up to one week post measurement	Yes