Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.
The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment|
- Acquisition of 24-hour Sensor output signal [ Time Frame: After 24-hour continuous recording ] [ Designated as safety issue: No ]Performance is assessed as the portion of valid data (actual number of valid data points recorded compared to expected number of recorded data points) during 24-hour recording.
- Possible IOP fluctuation [ Time Frame: After 24-hour recording with study device ] [ Designated as safety issue: No ]Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.
|Study Start Date:||September 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Experimental: SENSIMED Triggerfish||
Device: SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system