Continuous intraocular pressure monitoring with a sensing contact lens versus standard tonometry
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
This trial tests a smart contact lens that continuously measures eye pressure and compares its readings to standard tonometry in people with glaucoma or ocular hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sensimed AG Industry-sponsored |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT04024293 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares continuous intraocular pressure (IOP) measurements from a novel sensing contact lens to standard Goldmann applanation tonometry readings. Adult participants with primary open-angle glaucoma or ocular hypertension who meet corneal radius and thickness criteria will be enrolled, with exclusions for prior ocular surgery, corneal or conjunctival abnormalities, insufficient tear production, or contact-lens contraindications. Participants will wear the sensing contact lens while scheduled tonometry measurements are taken to compare the devices and characterize nycthemeral IOP fluctuations. The trial is single-site at Clinique Montchoisi in Lausanne and is sponsored by Sensimed AG.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with primary open-angle glaucoma or ocular hypertension, open angles on gonioscopy, central corneal radii between 7.3 and 8.05 mm with ≤2D difference between eyes, central corneal thickness 490–600 µm, and no contraindications to contact lens wear or the study medications.
Not a fit: Patients with other ocular pathology, prior glaucoma/cataract/refractive surgery, corneal or conjunctival abnormalities, insufficient lacrimal secretion, allergy to corneal anesthetic, or any contraindication to silicone contact-lens wear are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could reveal nighttime and activity-related pressure spikes that standard clinic checks miss, enabling more personalized treatment to help slow glaucoma progression.
How similar studies have performed: Previous studies using similar sensing contact lenses have demonstrated feasible continuous IOP-related signal recording and detection of nocturnal fluctuations, though they do not yet provide direct, interchangeable Goldmann-equivalent pressure values.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lausanne, Canton of Vaud
- Clinique Montchoisi — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Kaweh Mansouri, Pr — Swiss Glaucoma Foundation
- Study coordinator: Kaweh Mansouri, Pr
- Email: kwmansouri@gmail.com
- Phone: +41 21 619 36 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.