Quick Measure Study for iCare ST500 and iCare IC200
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Icare Finland Oy
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers
Study Overview
Brief Summary
The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1. Age ≥ 18 years
Exclusion Criteria
- •Subjects with only one functional eye
- •Subjects having poor or eccentric fixation in the study eye
- •High corneal astigmatism >3D in the study eye
- •Central corneal scarring
- •History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
- •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
- •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
- •Cataract Extraction within last 2 months in the study eye
Arms & Interventions
iCare ST500 and iCare IC200 vs GAT and Tonovera
Intervention: iCare ST500 (Device)
iCare ST500 and iCare IC200 vs GAT and Tonovera
Intervention: iCare IC200 (Device)
iCare ST500 and iCare IC200 vs GAT and Tonovera
Intervention: GAT (Device)
iCare ST500 and iCare IC200 vs GAT and Tonovera
Intervention: Tonovera (Device)
Outcomes
Primary Outcomes
Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers
Time Frame: Through study completion, estimated 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 and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
Secondary Outcomes
No secondary outcomes reported