NCT01362868

Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	SENSIMED Triggerfish®	Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-05-30
• Last updated: 2011-11-09

Locations

1 site across 1 country: Switzerland