SENSIMED Triggerfish in Closed Eyes

NCT01938287 — Phase 4, Completed, 6 participants, Sensimed AG

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A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Pattern Recorded With SENSIMED Triggerfish® in Healthy Subjects With Closed Eye

Registry	NCT01938287
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	6 (Actual)
Sponsor	Sensimed AG (Industry)
Conditions	Glaucoma
Interventions	SENSIMED Triggerfish (Device)
Dates	start 2013-07-01, primary completion 2013-09-01, completion 2014-02-01, first posted 2013-09-10, last updated 2015-11-17
Locations	1 site in Switzerland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
SENSIMED Triggerfish	Experimental	Device: SENSIMED Triggerfish

SENSIMED Triggerfish (Device)

+Outcome measures

Primary outcomes

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 [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).

+Eligibility

Sex: All, ages: 18 Years to 100 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
HUG, Department of Ophthalmology, Glaucoma Sector	Geneva	Switzerland