Central Corneal Thickness With SENSIMED Triggerfish (09/08)

This study has been completed.

Sponsor:

Information provided by:

Sensimed AG

ClinicalTrials.gov Identifier:

NCT01210963

First received: September 27, 2010

Last updated: March 17, 2011

Last verified: March 2011

History of Changes

Purpose

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

Condition	Intervention
Glaucoma Ocular Hypertension	Device: SENSIMED Triggerfish

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Further study details as provided by Sensimed AG:

Primary Outcome Measures:

Pachymetry (central corneal thickness) [ Time Frame: after 8 hours nocturnal continuous IOP monitoring ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
SENSIMED Triggerfish	Device: SENSIMED Triggerfish Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Glaucoma and ocular hypertension patients, at least 18 years old and with stable IOP-lowering treatment (if any).

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210963

Locations

Germany
Augen- und Poliklinik, Universitätsklinikum Würzburg
Würzburg, Germany, 97080

Sponsors and Collaborators

Sensimed AG

Investigators

Principal Investigator:

Thomas Klink, PD Dr. med

Universitätsklinikum Würzburg

More Information

No publications provided

Responsible Party:	Priv. Doz. Dr. med. Thomas Klink, Universitätsklinikum Würzburg, Augen- und Poliklinik
ClinicalTrials.gov Identifier:	NCT01210963 History of Changes
Other Study ID Numbers:	09/08
Study First Received:	September 27, 2010
Last Updated:	March 17, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension

Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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