Assessment of a New Goldmann Applanation Tonometer

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 3

Conditions: Intraocular Pressure

Treatments: Device: Tonometry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00555763

1410

162/07

Details and patient eligibility

About

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.

Full 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).

Enrollment: 157 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

1

Active Comparator group

Treatment:

Device: Tonometry