SENSIMED Triggerfish in Closed Eyes

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Device: SENSIMED Triggerfish

• Registration Number: NCT01938287
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-26
• Primary Completion: 2013-09
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Study Completion: 2014-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SENSIMED Triggerfish	SENSIMED Triggerfish	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

HUG, Department of Ophthalmology, Glaucoma Sector; 🇨🇭 Geneva, Switzerland