Central Corneal Thickness With SENSIMED Triggerfish (09/08)

March 17, 2011 updated by: Sensimed AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Würzburg, Germany, 97080
        • Augen- und Poliklinik, Universitätsklinikum Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pachymetry (central corneal thickness)
Time Frame: after 8 hours nocturnal continuous IOP monitoring
after 8 hours nocturnal continuous IOP monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensimed AG

Investigators

  • Principal Investigator: Thomas Klink, PD Dr. med, Wuerzburg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

March 18, 2011

Last Update Submitted That Met QC Criteria

March 17, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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