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

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).

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure

• Study Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Glaucoma Service, Department of Opthalmology, Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 ANSI standard is 150. In order to aid enrollment of at least 40 eyes in each pressure range (7-16 mmHg, >16 to <23 mmHg and 23 mmHg or higher), subjects were invited to participate on the basis of prior knowledge of their IOP range. 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 IOP range.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Icare Finland Oy
• Investigators: Principal Investigator: Päivi Puska, MD, FEBO, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (Estimate): July 9, 2010

Study Record Updates

• Last Update Posted (Estimate): July 9, 2010
• Last Update Submitted That Met QC Criteria: July 8, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: Icare-0021