Clinical trial NCT03689088: Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Healthy
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of subjects completing 24-hour session with Goldfish
timeFrame: 24 hours
measure: Wearing discomfort of Goldfish based on visual analogue scale
timeFrame: 24 hours
measure: Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements
timeFrame: 24 hours
measure: Correlation between IOP and ocular pulse amplitude (OPA) assessed by Goldfish in the Goldfish eye and IOP and OPA measured by tonometry in the fellow eye
timeFrame: 24 hours
measure: Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: [W]-Eye clinic
Study officials:
affiliation: [W]-Eye Clinic
name: Robert Wasilewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: