iCare ST500 Clinical Trial

NCT05742009 | Completed

• 1 other identifier: TA04-185
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

iCare ST500 vs GAT and iCare IC200

EXPERIMENTAL

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).

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

Interventions

iCare ST500 DEVICE

Measurement of Intraocular Pressure (IOP)

iCare ST500 vs GAT and iCare IC200

GAT DEVICE

Measurement of Intraocular Pressure (IOP)

iCare ST500 vs GAT and iCare IC200

iCare IC200 DEVICE

Measurement of Intraocular Pressure (IOP)

iCare ST500 vs GAT and iCare IC200

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old

You may not qualify if:

• Subjects with only one functional eye
• Subjects having poor or eccentric fixation in the study eye(s)
• High corneal astigmatism \>3D in the study eye(s)
• Central corneal scarring
• History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
• Microphthalmos
• Buphthalmos
• Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
• Dry eyes (clinically significant)
• Lid squeezers - blepharospasm
• Nystagmus
• Keratoconus
• Any other corneal or conjunctival pathology or infection relevant to this study
• Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s)
• Cataract Extraction within last 2 months in the study eye(s)

Sponsors & Collaborators

• Icare Finland Oy: lead

Study Sites (1)

Nova Scotia Health/Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator cannot see the measurement results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 23, 2023
• Study Start: June 5, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)