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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689088
• Other study ID #: GF-1703
• Status: Completed
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: September 6, 2018

Study information

• Verified date: November 2018
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 6, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Healthy

Intervention

Device:
• Goldfish
Goldfish will be placed in the eye for 24h monitoring
• Tonometry
Fellow eye will be measured by tonometry

Locations

Country	Name	City	State
Poland	[W]-Eye clinic	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP	IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device	24 hours
Secondary	Percentage of subjects completing 24-hour session with Goldfish	Percentage of subject completing the session will be calculated at the end of the study	24 hours
Secondary	Wearing discomfort of Goldfish based on visual analogue scale	Tolerability of the Goldfish lens will be subjectively evaluated before and after GF wear using a visual analogue scale from 0 (no discomfort) to 100 (severe discomfort) mm	24 hours
Secondary	Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements	Percentage of valid measurement will be calculated at the end of each monitoring session	24 hours
Secondary	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	OPA will be extracted from the Goldfish signal in the Goldfish eye and measured by tonometry in the fellow eye. Both IOP and OPA measurement will be compared between fellow eyes	24 hours
Secondary	Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours	IOP signal acquired with Goldfish will be compared to BP signal assessed with a BP holter	24 hours