Quick Measure Study for iCare ST500 and iCare IC200

Icare

Status: Completed

Conditions: Intraocular Pressure

Treatments: Device: iCare ST500; Device: Tonovera; Device: iCare IC200; Device: GAT

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156630

TA04-310

Details and patient eligibility

About

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).

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

iCare ST500 and iCare IC200 vs GAT and Tonovera

Experimental group

Treatment:

Device: GAT

Device: Tonovera

Device: iCare IC200

Device: iCare ST500