Icare Versus Haag-Streit Applanation Tonometer

NCT01159340 | Completed

• 1 other identifier: Icare-0021
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Intraocular Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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 & Collaborators

• Icare Finland Oy: lead

Study Sites (1)

Glaucoma Service, Department of Opthalmology, Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Study Officials

• Päivi Puska, MD, FEBO

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 9, 2010
• Study Start: May 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 9, 2010

Record last verified: 2010-07

Locations

FI (1)