Central Corneal Thickness With SENSIMED Triggerfish

NCT ID: NCT01210963

Last Updated: 2011-03-18

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-02-28

Brief Summary

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Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SENSIMED Triggerfish

SENSIMED Triggerfish

Intervention Type DEVICE

Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

Interventions

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SENSIMED Triggerfish

Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* glaucoma and ocular hypertension scheduled for overnight hospitalisation
* stable IOP-lowering treatment since at least 4 weeks before study
* at least 18 years
* having provided informed consent

Exclusion Criteria

* contact lens wear within the last 2 years
* contraindication for silicone lean wear
* corneal abnormality in either eye
* ocular infection or inflammation
* history of ocular surgery within the last 3 months
* full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
* pregnancy and lactation
* patients not able to understand the nature of the research
* patients under tutelage
* patients committed to an institution by virtue of an order issued either by the courts or by an authority
* simultaneous participation in other clinical research
Minimum Eligible Age

18 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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Universitätsklinikum Würzburg, Augen- und Poliklinik

Principal Investigators

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Thomas Klink, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

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Augen- und Poliklinik, Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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09/08

Identifier Type: -

Identifier Source: org_study_id

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