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

September 27, 2010
March 17, 2011
September 2010
February 2011   (final data collection date for primary outcome measure)
Pachymetry (central corneal thickness) [ Time Frame: after 8 hours nocturnal continuous IOP monitoring ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01210963 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Central Corneal Thickness With SENSIMED Triggerfish
Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Glaucoma
  • Ocular Hypertension
Device: SENSIMED Triggerfish
Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation
SENSIMED Triggerfish
Intervention: Device: SENSIMED Triggerfish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01210963
09/08
No
Priv. Doz. Dr. med. Thomas Klink, Universitätsklinikum Würzburg, Augen- und Poliklinik
Sensimed AG
Not Provided
Principal Investigator: Thomas Klink, PD Dr. med Wuerzburg University Hospital
Sensimed AG
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP