Status:
NOT_YET_RECRUITING
Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry
Lead Sponsor:
Sensimed AG
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04024293
Start Date
July 1 2025
End Date
December 1 2025
Last Update
May 15 2025
Active Locations (1)
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1
Clinique Montchoisi
Lausanne, Canton of Vaud, Switzerland, 1006