Clinical trial NCT01906502: 24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population
Official title: A Prospective, Open Label Study to Assess the 24-hour IOP Pattern Recorded With SENSIMED Triggerfish® in a Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary
timeFrame: 24-hour
Secondary outcomes:
measure: Diurnal and nocturnal IOP patterns in healthy subjects
timeFrame: 24 hours
measure: Assessment of corneal biomechanical properties in healthy population (if available)
timeFrame: 24 hours
measure: Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available)
timeFrame: 24 hours
measure: Assessment of Safety and tolerability through adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Naharya
country: Israel
facility: The Western Galilee Hospital in Naharya
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Lusky, MD
role: PRINCIPAL_INVESTIGATOR
References: