NCT01390779

Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Primary Open Angle Glaucoma
• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	SENSIMED Triggerfish	Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-07-11
• Last updated: 2014-01-20
• Results posted: 2014-01-20

Locations

1 site across 1 country: United States