Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Goldfish (GF)
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Informed Consent
- A clinical diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma (NTG), for OAG patients
- A clinical diagnosis of OHT, for OHT patients
- For all patients:
Open angles on gonioscopy Aged ≥ 18 years, either gender Both central corneal radii (CCR) between 7.3mm (46.23D) and 8.05mm (41.93D), with a maximum difference of 2D between the 2 radii in the study eye Central corneal thickness (CCT) between 490µm and 600µm in the study eye
Exclusion Criteria:
- Ocular pathology (other than glaucoma or OHT)
- Previous glaucoma, cataract or refractive laser/surgery
- Corneal or conjunctival abnormality, precluding contact lens adaptation
- Insufficiency of lacrimal secretion
- Subjects with allergy to corneal anesthetic
- Subjects with contraindications for silicone contact lens wear
- Subjects with contraindications for Diamox or Latanoprost or Timolol
- Skin irritations, skin eczema or other indications against the wearing of adhesive patches
- Subjects unable or unwilling to comply with the study procedures
- Subjects lacking the capacity to consent (vulnerable persons)
- Subjects with history of cardiac failure, treated cardiopathy or renal failure
- Subjects with known cognitive disorders
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Sites / Locations
- Clinique Montchoisi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
All patients will be follow the same procedures and be placed the investigational device
Outcomes
Primary Outcome Measures
GF IOP measurement as compared to IOP
Differences between GF IOP measurements at the recording start/end and the values obtained by GAT before/after GF SCL placement/removal, in the same eye
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04024293
Brief Title
Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry
Official Title
A Prospective Single Center Open Label Study Assessing Intraocular Pressure Measurements Using a Novel Sensing Contact Lens-based Device as Compared to Standard Tonometry, in Open Angle Glaucoma and Ocular Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma.
IOP is known to vary with the time of day as well as with daily activities. The importance of the nycthemeral IOP pattern for successful management of glaucoma has been well documented, especially for patients who experience visual loss despite apparently normal and/or controlled IOP during office hours.
The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, once per hour in the best cases. Since its development in the 50s, Goldmann applanation tonometry (GAT) has remained the gold standard method for measuring IOP, despite its limitations. However, tonometry may be an imperfect method for measuring changes in IOP because it allows only snapshot and non-continuous measurements, it is not physiologic and disturbs the sleep architecture.
There have been many efforts in the past decades to search for an ambulatory and frequent method to monitor IOP for 24 hours. In this context, Sensimed AG has recently developed a sensing contact lens-based device intended to measure IOP over 24 hours, the Goldfish (GF).
First-in-man data obtained with this device showed agreements between IOP measured by GF and values obtained by standard tonometry in the same eye, comparable to literature results for routinely used tonometry devices. However, this pilot study included 9 subjects only with improvable safety, tolerability and efficacy profiles.
The main goal of this study is to assess IOP measurements with the GF and compare the values with those obtained by standard tonometry in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
All patients will be follow the same procedures and be placed the investigational device
Intervention Type
Device
Intervention Name(s)
Goldfish (GF)
Intervention Description
The GF lens (SCL) will be place on participant's eye for a 24h IOP recording session
Primary Outcome Measure Information:
Title
GF IOP measurement as compared to IOP
Description
Differences between GF IOP measurements at the recording start/end and the values obtained by GAT before/after GF SCL placement/removal, in the same eye
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed Consent
A clinical diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma (NTG), for OAG patients
A clinical diagnosis of OHT, for OHT patients
For all patients:
Open angles on gonioscopy Aged ≥ 18 years, either gender Both central corneal radii (CCR) between 7.3mm (46.23D) and 8.05mm (41.93D), with a maximum difference of 2D between the 2 radii in the study eye Central corneal thickness (CCT) between 490µm and 600µm in the study eye
Exclusion Criteria:
Ocular pathology (other than glaucoma or OHT)
Previous glaucoma, cataract or refractive laser/surgery
Corneal or conjunctival abnormality, precluding contact lens adaptation
Insufficiency of lacrimal secretion
Subjects with allergy to corneal anesthetic
Subjects with contraindications for silicone contact lens wear
Subjects with contraindications for Diamox or Latanoprost or Timolol
Skin irritations, skin eczema or other indications against the wearing of adhesive patches
Subjects unable or unwilling to comply with the study procedures
Subjects lacking the capacity to consent (vulnerable persons)
Subjects with history of cardiac failure, treated cardiopathy or renal failure
Subjects with known cognitive disorders
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
Participation in another study with investigational drug within the 30 days preceding and during the present study,
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaweh Mansouri, Pr
Phone
+41 21 619 36 02
Email
kwmansouri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaweh Mansouri, Pr
Organizational Affiliation
Swiss Glaucoma Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Montchoisi
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1006
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaweh Mansouri, Pr
Phone
+41 21 619 36 02
Email
kwmansouri@gmail.com
12. IPD Sharing Statement
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Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry
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