Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
157 participants
INTERVENTIONAL
2007-08-31
2008-07-31
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
Tonometry
Tonometry : measurement of intraocular pressure with an applanation tonometer
Interventions
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Tonometry
Tonometry : measurement of intraocular pressure with an applanation tonometer
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
Yes
Sponsors
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Haag-Streit AG
INDUSTRY
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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University Hospital Inselspital; Berne
Principal Investigators
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Milko E Iliev, MD
Role: PRINCIPAL_INVESTIGATOR
University Eye Hospital Berne
Sebastian Wolf, MD
Role: STUDY_DIRECTOR
University Eye Hospital Berne
Locations
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University Eye Hospital Berne
Bern, Canton of Bern, Switzerland
Countries
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References
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SCHMIDT TA. The clinical application of the Goldmann applanation tonometer. Am J Ophthalmol. 1960 May;49:967-78. doi: 10.1016/0002-9394(60)91818-3. No abstract available.
GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.
GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. doi: 10.1159/000303213. No abstract available. German.
Other Identifiers
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162/07
Identifier Type: -
Identifier Source: secondary_id
1410
Identifier Type: -
Identifier Source: org_study_id
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