SENSIMED Triggerfish® in Sitting and Supine Position (NCT01347229) | Clinical Trial Compass
CompletedNot Applicable
SENSIMED Triggerfish® in Sitting and Supine Position
Israel20 participantsStarted 2011-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Difference in study device signal and GAT IOP between the sitting and supine positions during the sitting-supine sequence