iCare ST500 Clinical Trial
Not Applicable
Completed
- Conditions
- Intraocular Pressure
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
- Patients at least 18 years old
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie intraocular pressure measurement accuracy in rebound tonometry compared to Goldmann applanation tonometry?
How does the iCare ST500 device compare to standard-of-care Goldmann applanation tonometry in measuring intraocular pressure?
Are there specific ocular biomarkers that influence the performance of rebound tonometers like iCare ST500 in glaucoma patients?
What are the potential adverse events associated with rebound tonometry devices in ophthalmic clinical practice?
What are the key differences in intraocular pressure measurement between iCare ST500 and other rebound tonometers like iCare IC200?
Trial Locations
- Locations (1)
Nova Scotia Health/Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
Nova Scotia Health/Dalhousie University🇨🇦Halifax, Nova Scotia, Canada