Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

SENSIMED Triggerfish in Closed Eyes

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: NCT01938287
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Sensimed AG

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: SENSIMED Triggerfish Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SENSIMED Triggerfish Device: SENSIMED Triggerfish



Primary Outcome Measures :
  1. 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 [ Time Frame: 24 hours ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT01938287


Locations
Layout table for location information
Switzerland
HUG, Department of Ophthalmology, Glaucoma Sector
Geneva, Switzerland
Sponsors and Collaborators
Sensimed AG

Layout table for additonal information
Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01938287     History of Changes
Other Study ID Numbers: TF-1301
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015