SENSIMED Triggerfish Discomfort During IOP Monitoring
Completed
- Conditions
- Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
- Registration Number
- NCT00966108
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocular discomfort on a visual analogue scale 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz🇩🇪Mainz, Rheinland-Pfalz, Germany