NCT03689088

Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure

A Prospective Pilot Study Investigating the Use of a Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure in Healthy Subjects and Patients With Open Angle Glaucoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sensimed AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Glaucoma is characterized by irreversible vision loss through the progressive death of optic nerve fibers unless timely diagnosis and adequate treatment are provided. Medical therapy is aimed at lowering intraocular pressure (IOP) below a clinically determined target level in order to prevent or slow glaucoma progression. IOP is known to vary with the time of day as well as with daily activities. The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, allowing only snapshot and non-continuous measurements once per hour in the best cases. The procedure is cumbersome, expensive, inconvenient (disturbed sleep cycle as patient is awoken for nocturnal/sleep period measurements) and may not detect crucial IOP values in time. Sensimed AG has developed a new contact lens (CL)-based device intended to continuously measure IOP over 24 hours. The objective of this study is to investigate the use of device for 24-hour IOP monitoring in healthy subjects and glaucoma patients.

Conditions

• Glaucoma, Open-Angle
• Healthy

Interventions

Type	Name	Description
DEVICE	Goldfish	Goldfish will be placed in the eye for 24h monitoring
DEVICE	Tonometry	Fellow eye will be measured by tonometry

Timeline

• Start date: 2018-05-22
• Primary completion: 2018-07-04
• Completion: 2018-09-06
• First posted: 2018-09-28
• Last updated: 2018-12-04

Locations

1 site across 1 country: Poland