Icare Versus Haag-Streit Applanation Tonometer

Intraocular Pressure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159340
• Other study ID #: Icare-0021
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: July 8, 2010
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2010
• Source: Icare Finland Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care Ethics
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Intraocular Pressure

Locations

Country	Name	City	State
Finland	Glaucoma Service, Department of Opthalmology, Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Icare Finland Oy

Country where clinical trial is conducted

Finland,