SENSIMED Triggerfish
DeviceSoft contact lens-based device for the continuous monitoring of IOP fluctuations
NCT Number: NCT01319604
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
University Hospital Leuven, Leuven, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
Tonometric assessment of IOP
Time frame: during 24 hours of study device wear
Sensimed AG
Industry
Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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