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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05742009
Other study ID # TA04-185
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2023
Est. completion date November 14, 2023

Study information

Verified date November 2023
Source Icare Finland Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date November 14, 2023
Est. primary completion date November 14, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
iCare ST500
Measurement of Intraocular Pressure (IOP)
GAT
Measurement of Intraocular Pressure (IOP)
iCare IC200
Measurement of Intraocular Pressure (IOP)

Locations

Country Name City State
Canada Nova Scotia Health/Dalhousie University Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Icare Finland Oy

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demonstrate compliance with ANSI Z80.10:2014-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 measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups. Through study completion, an average of 4 months
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