Quick Measure Study for iCare ST500 and iCare IC200

Icare Finland Oy122 enrolled

Overview

The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

122

Conditions

Intraocular Pressure

Interventions

iCare ST500DEVICE

Measurement of IOP

iCare IC200DEVICE

Measurement of IOP

GATDEVICE

Measurement of IOP

Tonovera

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Age ≥ 18 years Exclusion Criteria: 1. Subjects with only one functional eye 2. Subjects having poor or eccentric fixation in the study eye 3. High corneal astigmatism \>3D in the study eye 4. Central corneal scarring 5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye 6. Microphthalmos 7. Buphthalmos 8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally 9. Dry eyes (clinically significant) 10. Lid squeezers - blepharospasm 11. Nystagmus 12. Keratoconus 13. Any other corneal or conjunctival pathology or infection relevant to this study 14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye 15. Cataract Extraction within last 2 months in the study eye

Locations (1)

NVision Clinical Research LLC

Torrance, California, United States

Outcomes

Primary Outcomes

Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers

Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Time frame: Through study completion, estimated 4 months

Data from ClinicalTrials.gov

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