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SENSIMED Triggerfish Discomfort During IOP Monitoring (09/02)

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ClinicalTrials.gov Identifier: NCT00966108
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : February 4, 2010
Information provided by:
Sensimed AG

Brief Summary:
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 or disease Intervention/treatment
Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients Device: SENSIMED Triggerfish

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients
Study Start Date : August 2009
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. ocular discomfort on a visual analogue scale [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy subjects and glaucoma patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966108

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

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
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases