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Central Corneal Thickness With SENSIMED Triggerfish (09/08)

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ClinicalTrials.gov Identifier: NCT01210963
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : March 18, 2011
Information provided by:
Sensimed AG

Brief Summary:
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 or disease Intervention/treatment
Glaucoma Ocular Hypertension Device: SENSIMED Triggerfish

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish
Study Start Date : September 2010
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
SENSIMED Triggerfish Device: SENSIMED Triggerfish
Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation

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

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).

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

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

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

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 Posted: September 29, 2010    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases