SENSIMED Triggerfish
This study has been completed.
Sponsor:
Sensimed AG
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01319604
First received: March 18, 2011
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Device: SENSIMED Triggerfish Device: Tonometer |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Sensimed AG:
Primary Outcome Measures:
- Relationship between study device signal and tonometer reading [ Time Frame: during 24 hours of study device wear ] [ Designated as safety issue: No ]
| Enrollment: | 59 |
| Study Start Date: | March 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319604
Locations
| 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
| Principal Investigator: | Milko Iliev, MD | University of Bern |
More Information
No publications provided
| Responsible Party: | Sensimed AG |
| ClinicalTrials.gov Identifier: | NCT01319604 History of Changes |
| Other Study ID Numbers: | 10/01 |
| Study First Received: | March 18, 2011 |
| Last Updated: | August 7, 2012 |
| Health Authority: | Switzerland: Swiss Agency for Therapeutic Products |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013