SENSIMED Triggerfish
Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring
1 other identifier
interventional
59
4 countries
5
Brief Summary
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 8, 2012
August 1, 2012
1.2 years
March 18, 2011
August 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Relationship between study device signal and tonometer reading
during 24 hours of study device wear
Study Arms (9)
Study device during 3 hours
EXPERIMENTALStudy device during 6 hours
EXPERIMENTALStudy device during 9 hours
EXPERIMENTALStudy device during 12 hours
EXPERIMENTALStudy device during 15 hours
EXPERIMENTALStudy device during 18 hours
EXPERIMENTALStudy device during 21 hours
EXPERIMENTALStudy device during 24 hours
EXPERIMENTALTonometric assessment during 24 hours
ACTIVE COMPARATORInterventions
Soft contact lens-based device for the continuous monitoring of IOP fluctuations
Eligibility Criteria
You may qualify if:
- Signed informed consent for the investigation
- Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
- Age 18-85
- Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation
You may not qualify if:
- Patients not able to understand the character and individual consequences of the investigation
- Patients with contraindications for silicone contact lens wear
- Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
- Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
- Severe dry eye
- Patients who have had ocular surgery within the last 3 months
- Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
- Allergy to corneal anaesthesia
- Simultaneous participation in other clinical research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sensimed AGlead
Study Sites (5)
University Hospital Leuven
Leuven, 3000, Belgium
University Hospital Glostrup
Glostrup Municipality, 2600, Denmark
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitari i Politècnic la Fe
Valencia, 46026, Spain
Inselspital
Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milko Iliev, MD
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 21, 2011
Study Start
March 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 8, 2012
Record last verified: 2012-08