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Icare Versus Haag-Streit Applanation Tonometer

This study has been completed.
Sponsor:
Information provided by:
Icare Finland Oy
ClinicalTrials.gov Identifier:
NCT01159340
First received: June 30, 2010
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

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).


Condition
Intraocular Pressure

Study Type: Observational
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

Further study details as provided by Icare Finland Oy:

Enrollment: 260
Study Start Date: May 2009
Study Completion Date: November 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159340

Locations
Finland
Glaucoma Service, Department of Opthalmology, Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Icare Finland Oy
Investigators
Principal Investigator: Päivi Puska, MD, FEBO Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Markku Eraluoto, CTO, Icare Finland Oy
ClinicalTrials.gov Identifier: NCT01159340     History of Changes
Other Study ID Numbers: Icare-0021
Study First Received: June 30, 2010
Last Updated: July 8, 2010
Health Authority: Finland: National Advisory Board on Health Care Ethics

ClinicalTrials.gov processed this record on May 19, 2013