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OpenTrials
Completed

NCT Number: NCT00555763

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Eye Hospital Berne

Bern, Canton of Bern, 3010, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tonometry

Device

Tonometry : measurement of intraocular pressure with an applanation tonometer

Primary outcomes

  1. Intraocular Pressure in mmHG

    Time frame: single event

Secondary outcomes

  1. safety of measurement

    Time frame: single event, up to one week post measurement

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Haag-Streit AG

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 9, 2007
Registry last updated
Jul 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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