Clinical trial NCT00555763: Assessment of a New Goldmann Applanation Tonometer
Official title: Assessment of a New Goldmann Applanation Tonometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intraocular Pressure
Keywords: Intraocular pressure
Goldmann tonometry
applanation tonometry
Tonometry, Ocular
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Haag-Streit AG
First posted: 2007-11-09
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Intraocular Pressure in mmHG
timeFrame: single event
Secondary outcomes:
measure: safety of measurement
timeFrame: single event, up to one week post measurement
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Eye Hospital Berne
Study officials:
affiliation: University Eye Hospital Berne
name: Milko E Iliev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Eye Hospital Berne
name: Sebastian Wolf, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.
citation: GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. doi: 10.1159/000303213. No abstract available. German.