Assessment of a New Goldmann Applanation Tonometer

July 13, 2011 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3010
        • University Eye Hospital Berne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Device: Tonometry
Tonometry : measurement of intraocular pressure with an applanation tonometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure in mmHG
Time Frame: single event
single event

Secondary Outcome Measures

Outcome Measure
Time Frame
safety of measurement
Time Frame: single event, up to one week post measurement
single event, up to one week post measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Haag-Streit AG

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria

November 8, 2007

First Posted (Estimate)

November 9, 2007

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1410
  • 162/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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