Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
Conditions
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
Interventions
Ocular Telemetry Sensor for IOP monitoring
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ocular discomfort on a visual analogue scale | 24 hours |
Countries
Germany