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SENSIMED Triggerfish in Closed Eyes

NCT ID: NCT01938287

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SENSIMED Triggerfish

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Interventions

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SENSIMED Triggerfish

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sensimed AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HUG, Department of Ophthalmology, Glaucoma Sector

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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TF-1301

Identifier Type: -

Identifier Source: org_study_id