NCT01347229

SENSIMED Triggerfish® in Sitting and Supine Position

Assessment of Sitting and Supine Position IOP Using SENSIMED Triggerfish® and Standard Tonometers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

20 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 22-hour continuous IOP monitoring with SENSIMED Triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. 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. Subjects will then go home. The next morning, subjects will return to the hospital and during SENSIMED Triggerfish® monitoring on one eye, IOP measurements will be taken in the fellow eye in sitting position using Goldmann, tonopen and pneuma-tonometers. Then subjects will lie down on a flat bed. After 15 ± 5 minutes and again after 45 ± 5 minutes IOP will be measured in supine position, using Goldmann, tonopen, pneuma-tonometer and Perkins tonometers. Then subjects will sit up again. After 30 ± 5 minutes IOP will be measured with the Goldmann tonometer.

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: 2011-04-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2011-05-04
• Last updated: 2012-04-17

Locations

1 site across 1 country: Israel