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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Wuerzburg University Hospital
  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 July 23, 2014