Viewing Study NCT01390779



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Last Modification Date: 2024-10-26 @ 10:37 AM
Study NCT ID: NCT01390779
Status: COMPLETED
Last Update Posted: 2014-01-20
First Post: 2011-07-07

Brief Title: Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
Sponsor: Sensimed AG
Organization: Sensimed AG

Study Overview

Official Title: Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
Status: COMPLETED
Status Verified Date: 2013-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None