Back to resultsSENSIMED Triggerfish in Closed Eyes
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Healthy subject without previous ophthalmic medical history (except from indication for glasses)
- Aged ≥18 years, of either sex
- Have given written informed consent, prior to any investigational procedures
Exclusion Criteria:
- Patients with allergy to corneal anesthetic
- Patients with contraindications for silicone contact lens wear
- Patients not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
Sites / Locations
- HUG, Department of Ophthalmology, Glaucoma Sector
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SENSIMED Triggerfish
Arm Description
Outcomes
Primary Outcome Measures
The difference between start and end TF (SENSIMED Triggerfish) in a closed eye as compared to the difference between start to end TF in an open eye
TF will be installed on subjects' eyes for 24 hours in two sessions. In one session the eye will remain open (except during sleep) while in the other session the eye will be closed using an ophthalmic patch throughout the 24 hours. For both sessions, the initial TF output value in millivolt equivalent will be subtracted from the final output value to yield the difference from start to end. The difference obtained in the session with closed eye will be divided by that of the session with open eye (ratio).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01938287
Brief Title
SENSIMED Triggerfish in Closed Eyes
Official Title
A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Pattern Recorded With SENSIMED Triggerfish® in Healthy Subjects With Closed Eye
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the effect of eye opening/closure on the quality of IOP (intraocular pressure) related patterns recorded with SENSIMED Triggerfish. Each subject receives 2 24-hour recording sessions, one with the recorded eye open and the other with the eye closed,using an ophthalmic patch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SENSIMED Triggerfish
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Primary Outcome Measure Information:
Title
The difference between start and end TF (SENSIMED Triggerfish) in a closed eye as compared to the difference between start to end TF in an open eye
Description
TF will be installed on subjects' eyes for 24 hours in two sessions. In one session the eye will remain open (except during sleep) while in the other session the eye will be closed using an ophthalmic patch throughout the 24 hours. For both sessions, the initial TF output value in millivolt equivalent will be subtracted from the final output value to yield the difference from start to end. The difference obtained in the session with closed eye will be divided by that of the session with open eye (ratio).
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subject without previous ophthalmic medical history (except from indication for glasses)
Aged ≥18 years, of either sex
Have given written informed consent, prior to any investigational procedures
Exclusion Criteria:
Patients with allergy to corneal anesthetic
Patients with contraindications for silicone contact lens wear
Patients not able to understand the character and individual consequences of the investigation
Participation in other clinical research within the last 4 weeks
Facility Information:
Facility Name
HUG, Department of Ophthalmology, Glaucoma Sector
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
SENSIMED Triggerfish in Closed Eyes
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