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Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

NCT ID: NCT01391078

Last Updated: 2012-11-28

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma

Keywords

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glaucoma IOP Sensimed Triggerfish Goldmann Applanation Tonometry fluctuation comparison

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sensimed Triggerfish

Group Type EXPERIMENTAL

Sensimed Triggerfish Sensor

Intervention Type DEVICE

IOP will be monitored for 24 hours

Goldmann Applanation Tonometry/Perkins Tonometry

Group Type ACTIVE_COMPARATOR

Goldmann Applanation Tonometry, Perkins Tonometry

Intervention Type DEVICE

IOP will be measured every two hours within 24 hours

Interventions

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Sensimed Triggerfish Sensor

IOP will be monitored for 24 hours

Intervention Type DEVICE

Goldmann Applanation Tonometry, Perkins Tonometry

IOP will be measured every two hours within 24 hours

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is able to comply with the study procedure
* Patient must be ≥ 18 years old
* Diagnosis of primary open angle glaucoma (EGS criteria)
* Similar behaviour of IOP in both eyes in former IOP profiles
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Visual Acuity of 20/200 or better in both eyes
* Ability of subject to understand the character and individual consequences of the study
* For women with childbearing potential, adequate contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sensimed AG

INDUSTRY

Sponsor Role collaborator

Katrin Lorenz

OTHER

Sponsor Role lead

Responsible Party

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Katrin Lorenz

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz

Mainz, RLP, Germany

Site Status

Countries

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Germany

Other Identifiers

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Sensimed Triggerfish11/01

Identifier Type: -

Identifier Source: org_study_id