Assessment of a New Goldmann Applanation Tonometer

NCT ID: NCT00555763

Last Updated: 2011-07-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Tonometry

Intervention Type DEVICE

Tonometry : measurement of intraocular pressure with an applanation tonometer

Interventions

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Tonometry

Tonometry : measurement of intraocular pressure with an applanation tonometer

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Haag-Streit AG

INDUSTRY

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

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

Site Status

Countries

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Switzerland

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.

Reference Type BACKGROUND
PMID: 14443098 (View on PubMed)

GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.

Reference Type BACKGROUND
PMID: 13706587 (View on PubMed)

GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. doi: 10.1159/000303213. No abstract available. German.

Reference Type BACKGROUND
PMID: 13484216 (View on PubMed)

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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