Healthy Subjects Clinical Trial
Official title:
Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
The objectives of this study are to assess the safety and effectiveness of the SENSIMED
Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular
pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of
continuous TF recording.
TF efficacy will be evaluated by demonstrating TF ability to detect:
1. The known phenomenon of increase in IOP when moving from waking state to going to bed,
as reflected in pneumotonometer measurements
2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).
A screening visit and one 24-hour IOP fluctuation recording session are planned for each
patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An
ophthalmological examination of the eyes will be done at screening and prior to and
following the device recording.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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