SENSIMED Triggerfish Discomfort During IOP Monitoring (09/02)

February 3, 2010 updated by: Sensimed AG

Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy subjects and glaucoma patients

Description

Inclusion Criteria:

  • Patient is able to comply with the study procedure
  • Patient is 18-80 years old
  • Healthy subject or glaucoma patient
  • Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
  • Cylinder refraction of no more than +/- 2 diopters in the study eye
  • Visual acuity of 20/80 or better in the study eye
  • Ability of subject to understand the character and individual consequences of the study
  • For women with childbearing potential, adequate contraception

Exclusion Criteria:

  • Subjects wearing contact lenses within the last two years
  • Subjects with contraindications for wearing contact lenses
  • History of refractive surgery
  • History of intraocular surgery in the last three months
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormalities
  • Conjunctival or intraocular inflammation
  • Pregnancy and lactation
  • Simultaneous participation in other clinical trials

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
Healthy subjects
Device: SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring
Glaucoma patients
Device: SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ocular discomfort on a visual analogue scale
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Sensimed AG

Investigators

  • Principal Investigator: Norbert Pfeiffer, Prof. Dr. med., Universitätsmedizin Mainz

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

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/02

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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