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

Sensimed

Status

Completed

Conditions

Healthy

Glaucoma, Open-Angle

Treatments

Device: Goldfish

Device: Tonometry

Study type

Interventional

Funder types

Industry

Identifiers

NCT03689088

GF-1703

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For Open Angle Glaucoma (OAG) subjects, a clinical diagnosis of primary OAG, including normal tension glaucoma (NTG) all known untreated IOP measurements < 22 mmHg using Goldmann Applanation Tonometry (GAT) for NTG no IOP-lowering treatment; otherwise, a 4-week wash-out period prior to the recording
For healthy subjects, no structural defects, normal visual fields, IOP ≤ 21 mmHg and open angles on gonioscopy
Aged ≥ 18 years, either gender
Body Mass Index ≤ 30 kg/m2
Central Corneal Radius (flat meridian) between 7.5 mm (45 D) and 7.9 mm (42.75 D)
Central Corneal Thickness between 500 microns and 600 microns
Difference in IOP absolute value between eyes within 2.5 mmHg at screening in sitting position
Same direction of IOP variation (positive or negative) for the 2 eyes when moving from sitting to supine positions at screening
Spherical refraction within ±6.00 diopters and cylinder refraction within ±3.00 diopters
Having given written informed consent, prior to any investigational procedures

Exclusion criteria

Ocular pathology (other than glaucoma for glaucoma subjects)
Previous glaucoma, cataract or refractive surgery
Corneal or conjunctival abnormality, precluding contact lens adaptation
Severe dry eye syndrome
Subjects with allergy to corneal anesthetic
Subjects with contraindications for silicone CL wear
Subjects with contraindications for Water Drinking Test (WDT) (eg., heart, renal problems)
Subjects unable or unwilling to comply with the study procedures
Participation in other interventional clinical research within the last 4 weeks