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
  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 ] [ 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 April 17, 2014