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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689088
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Sensimed AG

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.


Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Healthy Device: Goldfish Device: Tonometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Actual Study Start Date : May 22, 2018
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : September 6, 2018


Arm Intervention/treatment
Experimental: Investigational device (Goldfish)
IOP will be monitored for 24 h in the Goldfish eye
Device: Goldfish
Goldfish will be placed in the eye for 24h monitoring

Active Comparator: Tonometry
IOP will be acquired by standard tonometry at specific times in the the fellow eye
Device: Tonometry
Fellow eye will be measured by tonometry




Primary Outcome Measures :
  1. Changes in IOP assessed by Goldfish following known physiological and induced changes in IOP [ Time Frame: 24 hours ]
    IOP will be measured using tonometry in the fellow eye and compared to IOP measured in the Goldfish eye with the Goldfish device


Secondary Outcome Measures :
  1. Percentage of subjects completing 24-hour session with Goldfish [ Time Frame: 24 hours ]
    Percentage of subject completing the session will be calculated at the end of the study

  2. Wearing discomfort of Goldfish based on visual analogue scale [ Time Frame: 24 hours ]
    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

  3. Evaluation of Goldfish technical performance based on the percentage of valid Goldfish measurements [ Time Frame: 24 hours ]
    Percentage of valid measurement will be calculated at the end of each monitoring session

  4. 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 [ Time Frame: 24 hours ]
    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

  5. Relationship between Goldfish IOP and blood pressure (BP) measurements over 24 hours [ Time Frame: 24 hours ]
    IOP signal acquired with Goldfish will be compared to BP signal assessed with a BP holter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689088


Locations
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Poland
[W]-Eye clinic
Poznań, Poland, 61-048
Sponsors and Collaborators
Sensimed AG
Investigators
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Principal Investigator: Robert Wasilewicz, MD [W]-Eye Clinic
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Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT03689088    
Other Study ID Numbers: GF-1703
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases