NCT01319604

SENSIMED Triggerfish

Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Detailed description

60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Conditions

• Glaucoma

Interventions

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

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-03-21
• Last updated: 2012-08-08

Locations

5 sites across 4 countries: Belgium, Denmark, Spain, Switzerland