Icare Versus Haag-Streit Applanation Tonometer

The clinical performance of Icare ONE Tonometer TA02 was compared to a Goldmann type applanation tonometer (Haag-Streit). Data was collected according to ANSI Z80.10-2003 (ISO 8612.2) standard. Subjects were eligible for the study if they had no exclusion criteria specified in the ANSI/ISO standard. One eye from 260 subjects was selected for the study. The minimum sample size according to the standard is 150. One eye of each subject was selected for the study by an investigator, based on the history of the patient, results of an external examination of the eye with slit lamp, keratometry readings, and prior knowledge of the intraocular pressure (IOP) range. The Icare ONE Tonometer TA02 in comparison to the reference tonometer (Goldmann type tonometer).

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Key information

Conditions

Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glaucoma Service, Department of Opthalmology, Helsinki University Central Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

subjects were eligible for the study if they had no exclusion criteria as specified by the ANSI/ISO standard

Subjects were selected according to the following exclusion criteria (as given in ANSI Z80.10-2003 and ISO 8612):

subjects with only one functional eye
those with one eye having poor or eccentric fixation
high corneal astigmatism (i.e. those eyes displaying an oval contact image with the Goldmann tonometer)
those with corneal scarring or who have had corneal surgery, including corneal laser surgery
microphthalmos
buphthalmos
contact lens wearers
dry eyes
lid squeezers (blepharospasm)
nystagmus
keratoconus
any other corneal or conjunctival pathology or infection

Sponsors and collaborators

Lead sponsor

Icare Finland Oy

Industry

Registry information

Official study title

Design Compliance Testing of the Icare One Rebound Tonometer According to the American National Standard ANSI Z80.10-2001 and International Standard ISO 8612.2 for Tonometers

Important dates

Study start: 2009
Study completion: 2009
First posted: Jul 9, 2010
Registry last updated: Jul 9, 2010

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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Completed