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Icare Versus Haag-Streit Applanation Tonometer

Sponsor
Icare Finland Oy (Industry)
Overall Status
Completed
CT.gov ID
NCT01159340
Collaborator
(none)
260
Enrollment
1
Location
6
Duration (Months)
43
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    260 participants
    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
    Study Start Date :
    May 1, 2009
    Actual Study Completion Date :
    Nov 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts 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 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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01159340
      Other Study ID Numbers:
      • Icare-0021
      First Posted:
      Jul 9, 2010
      Last Update Posted:
      Jul 9, 2010
      Last Verified:
      Jul 1, 2010

      Study Results

      No Results Posted as of Jul 9, 2010