Continuous intraocular pressure monitoring with a sensing contact lens versus standard tonometry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.