SENSIMED Triggerfish Discomfort During IOP Monitoring (09/02)

Sensimed

Status: Completed

Conditions: Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Treatments: Device: SENSIMED Triggerfish

Study type: Observational

Funder types: Industry

Identifiers

NCT00966108

09/02

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Healthy subjects

Treatment:

Device: SENSIMED Triggerfish

Glaucoma patients

Treatment:

Device: SENSIMED Triggerfish