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SENSIMED Triggerfish Discomfort During IOP Monitoring (09/02)

This study has been completed.
Sponsor:
Information provided by:
Sensimed AG
ClinicalTrials.gov Identifier:
NCT00966108
First received: August 24, 2009
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

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


Condition Intervention
Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
 Device: SENSIMED Triggerfish

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • ocular discomfort on a visual analogue scale [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy subjects Device: SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring
Glaucoma patients Device: SENSIMED Triggerfish
Ocular Telemetry Sensor for IOP monitoring

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy subjects and glaucoma patients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966108

Locations
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Sensimed AG
Investigators
Principal Investigator: Norbert Pfeiffer, Prof. Dr. med. Universitätsmedizin Mainz
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Norbert Pfeiffer, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
ClinicalTrials.gov Identifier: NCT00966108     History of Changes
Other Study ID Numbers: 09/02
Study First Received: August 24, 2009
Last Updated: February 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013