iCare ST500 Clinical Trial

Not Applicable

Completed

• Conditions: Intraocular Pressure
• Interventions: Device: iCare ST500; Device: GAT; Device: iCare IC200

• Registration Number: NCT05742009
• Lead Sponsor: Icare Finland Oy

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-06-05
• Status Verified: 2023-11
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iCare ST500 vs GAT and iCare IC200	GAT	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).
iCare ST500 vs GAT and iCare IC200	iCare ST500	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).
iCare ST500 vs GAT and iCare IC200	iCare IC200	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).

Primary Outcome Measures

Name	Time	Method
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers	Through study completion, an average of 4 months	Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Trial Locations

Locations (1)

Nova Scotia Health/Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada