iCare ST500 Clinical Trial

Icare

Status: Completed

Conditions: Intraocular Pressure

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05742009

TA04-185

Details and patient eligibility

About

Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients at least 18 years old

Exclusion criteria

1. Subjects with only one functional eye
2. Subjects having poor or eccentric fixation in the study eye(s)
3. High corneal astigmatism >3D in the study eye(s)
4. Central corneal scarring
5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
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(s)
15. Cataract Extraction within last 2 months in the study eye(s)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

iCare ST500 vs GAT and iCare IC200

Experimental group

Description:

Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (≥23 mmHg).

Treatment:

Device: GAT

Device: iCare IC200

Device: iCare ST500