24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population

Not Applicable

Completed

• Conditions: Healthy Subject
• Interventions: Device: Sensimed Triggerfish

• Registration Number: NCT01906502
• Lead Sponsor: Sensimed AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-20
• Study First Posted: 2013-07-24
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	Sensimed Triggerfish	Portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.

Primary Outcome Measures

Name	Time	Method
The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary	24-hour

Secondary Outcome Measures

Name	Time	Method
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 corneal biomechanical properties in healthy population (if available)	24 hours
Assessment of Safety and tolerability through adverse events	6 months
Diurnal and nocturnal IOP patterns in healthy subjects	24 hours

Trial Locations

Locations (5)

The Western Galilee Hospital in Naharya; 🇮🇱 Naharya, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel