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Central Corneal Thickness With SENSIMED Triggerfish (09/08)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210963
First Posted: September 29, 2010
Last Update Posted: March 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sensimed AG
  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:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Pachymetry (central corneal thickness) [ Time Frame: after 8 hours nocturnal continuous IOP monitoring ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210963


Locations
Germany
Augen- und Poliklinik, Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Thomas Klink, PD Dr. med Wuerzburg University Hospital
  More Information

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
First Submitted: September 27, 2010
First Posted: September 29, 2010
Last Update Posted: March 18, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases