iCare ST500 Clinical Trial

Intraocular Pressure Clinical Trial

Official title:

Clinical Validation of a Slit Lamp Mounted Rebound Tonometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742009
• Other study ID #: TA04-185
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Intraocular Pressure

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