Icare Versus Haag-Streit Applanation Tonometer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Intraocular Pressure

Eligibility Criteria

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Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes