Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients
|ClinicalTrials.gov Identifier: NCT01263535|
Recruitment Status : Terminated
First Posted : December 20, 2010
Last Update Posted : August 28, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Device: SENSIMED Triggerfish||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Circadian Continuous Intraocular Pressure Monitoring With SENSIMED Triggerfish® Ocular Telemetry Sensor in Patients on Tafluprost Treatment|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||May 2012|
|Experimental: SENSIMED Triggerfish||
Device: SENSIMED Triggerfish
Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
- Acquisition of 24-hour Sensor output signal [ Time Frame: After 24-hour continuous recording ]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 ]Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263535
|University Hospital Geneva|
|Geneva, Switzerland, 1211|