Icare Versus Haag-Streit Applanation Tonometer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01159340

Enrollment

260

Registered

2010-07-09

Start date

2009-05-31

Completion date

2009-11-30

Last updated

2010-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Brief summary

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).

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Countries

Finland

Outcome results