Healthy Volunteers
Conditions
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.
Interventions
DEVICESENSIMED Triggerfish
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed