SENSIMED Triggerfish in Closed Eyes

Phase 4CompletedNCT01938287

Sensimed AG6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

SENSIMED TriggerfishDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

HUG, Department of Ophthalmology, Glaucoma Sector

Geneva, Switzerland

Outcomes

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

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

Data from ClinicalTrials.gov

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