Healthy Subject
Conditions
Brief summary
A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on healthy volunteers and patients with glaucoma. However, healthy subjects were much younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database was almost twice higher than the number of healthy subjects. As it is generally accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore, improving our knowledge of the healthy 24-hour IOP pattern in comparison to glaucoma profiles would be beneficial for management of glaucoma.
Interventions
DEVICESensimed Triggerfish
Sponsors
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject of Caucasian origin * Healthy subject without previous ocular disease * Aged between 40 and 80 years, of either sex * 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 * Previous refractive surgery * Occludable or closed iridocorneal angle * Sleep apnea 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary | 24-hour |
Secondary
| Measure | Time frame |
|---|---|
| Diurnal and nocturnal IOP patterns in healthy subjects | 24 hours |
| Assessment of corneal biomechanical properties in healthy population (if available) | 24 hours |
| Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available) | 24 hours |
| Assessment of Safety and tolerability through adverse events | 6 months |
Countries
Israel
Outcome results
None listed