SENSIMED Triggerfish

August 7, 2012 updated by: Sensimed AG

Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven
  • Denmark
      • Glostrup, Denmark, 2600
        • University Hospital Glostrup
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Valencia, Spain, 46026
        • Hospital Universitari I Politecnic La Fe
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship between study device signal and tonometer reading
Time Frame: during 24 hours of study device wear
during 24 hours of study device wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensimed AG

Investigators

  • Principal Investigator: Milko Iliev, MD, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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