Healthy Subjects Clinical Trial
Official title:
Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers
Verified date | April 2012 |
Source | Sensimed AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swiss Agency for Therapeutic Products |
Study type | Interventional |
The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is able to provide informed consent - Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism - No more than 4 diopters spherical equivalent - No more than 2 diopters cylinder equivalent - GAT IOP of less than or equal to 21 mmHg at inclusion and open iridocorneal angles, no history of any IOP > 21 mmHg - GAT IOP difference between eyes within 1 mmHg during initial exam - GAT IOP differences between initial sitting and supine positions, between left and right eyes, within 2 mmHg during initial exam - = 18 years - For women with childbearing potential, adequate contraception Exclusion Criteria: - Subjects with contraindications for wearing contact lenses - Severe dry eye syndrome - Keratoconus or other corneal abnormality - Conjunctival or intraocular inflammation - History of eye surgery - Full frame metal glasses during SENSIMED Triggerfish® recording - Known hypersensitivity to silicone, plaster or ocular anesthesia - Pregnancy and lactation - Simultaneous participation in other clinical studies |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Assaf Harofeh Medical Center | Zerifin |
Lead Sponsor | Collaborator |
---|---|
Sensimed AG |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence | 45 minutes | No | |
Secondary | Difference in Triggerfish® signal and GAT IOP between the sitting and supine positions upon returning to sitting position from supine | 30 minutes | No | |
Secondary | IOP measurements with tonopen and pneuma-tonometer in sitting position, and tonopen, pneuma-tonometer and Perkins in supine position | 2 hours | No | |
Secondary | Monitoring with study device obtained before Day 2 | 20 hours | No |
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