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

Sensimed

Status: Completed

Conditions: Healthy Subject

Treatments: Device: Sensimed Triggerfish

Study type: Interventional

Funder types: Industry

Identifiers

NCT01906502

TF-1217

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Device

Experimental group

Description:

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.

Treatment:

Device: Sensimed Triggerfish