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SENSIMED Triggerfish

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319604
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Sensimed AG

Brief Summary:
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Condition or disease Intervention/treatment Phase
Glaucoma Device: SENSIMED Triggerfish Device: Tonometer Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring
Study Start Date : March 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study device during 3 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 6 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 9 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 12 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 15 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 18 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 21 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Experimental: Study device during 24 hours Device: SENSIMED Triggerfish
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Active Comparator: Tonometric assessment during 24 hours Device: Tonometer
Tonometric assessment of IOP




Primary Outcome Measures :
  1. Relationship between study device signal and tonometer reading [ Time Frame: during 24 hours of study device wear ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319604


Locations
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Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Denmark
University Hospital Glostrup
Glostrup, Denmark, 2600
Spain
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitari i Politècnic la Fe
Valencia, Spain, 46026
Switzerland
Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
Sensimed AG
Investigators
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Principal Investigator: Milko Iliev, MD University of Bern
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Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01319604    
Other Study ID Numbers: 10/01
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases