SENSIMED Triggerfish Sensor Sizes
Phase 4
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- NCT01972997
- Lead Sponsor
- Sensimed AG
- Brief Summary
This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy subject without previous ocular disease
- Aged ≥ 18 years, of either sex
- Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye
- Not more than 6 diopters spherical equivalent in the study eye
- Having given written informed consent, prior to any investigational procedures
Exclusion Criteria
- Corneal or conjunctival abnormality precluding contact lens adaptation
- Severe dry eye syndrome
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for silicone contact lens wear
- Subjects not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Any other contra-indication listed in the TF user manual
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Clinico San Carlos🇪🇸Madrid, Spain