Status:
COMPLETED
SENSIMED Triggerfish Discomfort During IOP Monitoring
Lead Sponsor:
Sensimed AG
Conditions:
Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
Eligibility:
All Genders
18-80 years
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00966108
Start Date
August 1 2009
End Date
January 1 2010
Last Update
February 4 2010
Active Locations (1)
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1
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany, 55131