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SENSIMED Triggerfish

NCT ID: NCT01319604

Last Updated: 2012-08-08

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

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Detailed Description

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60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study device during 3 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 6 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 9 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 12 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 15 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 18 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 21 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study device during 24 hours

Group Type EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Tonometric assessment during 24 hours

Group Type ACTIVE_COMPARATOR

Tonometer

Intervention Type DEVICE

Tonometric assessment of IOP

Interventions

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SENSIMED Triggerfish

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Intervention Type DEVICE

Tonometer

Tonometric assessment of IOP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent for the investigation
* Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
* Age 18-85
* Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation

Exclusion Criteria

* Patients not able to understand the character and individual consequences of the investigation
* Patients with contraindications for silicone contact lens wear
* Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
* Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
* Severe dry eye
* Patients who have had ocular surgery within the last 3 months
* Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
* Allergy to corneal anaesthesia
* Simultaneous participation in other clinical research
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sensimed AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milko Iliev, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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University Hospital Leuven

Leuven, , Belgium

Site Status

University Hospital Glostrup

Glostrup Municipality, , Denmark

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitari i Politècnic la Fe

Valencia, , Spain

Site Status

Inselspital

Bern, , Switzerland

Site Status

Countries

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Belgium Denmark Spain Switzerland

Other Identifiers

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10/01

Identifier Type: -

Identifier Source: org_study_id