Healthy Subjects Clinical Trial
Official title:
Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.
32 subjects will be enrolled in the investigation. Eligible subjects will receive one
session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water
drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes
and the IOP recording will be initiated as soon as the adaptation of the device on the
subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60
minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will
be measured on the contra lateral eye using Goldmann tonometer and the subjects will be
asked to drink 1 liter of water within 5 minutes.
After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after
the beginning of the test then every 5 minutes until returned to normal. The IOP will be
measured again every 20 minutes until 2 hours after the water drinking.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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