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Icare Versus Haag-Streit Applanation Tonometer

NCT01159340 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2010-07-09

No results posted yet for this study

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

Sponsors & Collaborators

  • Icare Finland Oy

    lead INDUSTRY

Principal Investigators

  • Päivi Puska, MD, FEBO · Helsinki University Central Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Completion
2009-11-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159340 on ClinicalTrials.gov