Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry

Launched by SENSIMED AG · Jul 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new contact lens device designed to measure eye pressure (intraocular pressure or IOP) continuously over a 24-hour period. This is important for patients with glaucoma or ocular hypertension, as fluctuations in eye pressure can occur throughout the day and night. Currently, the standard method of measuring IOP, called tonometry, only provides snapshots of eye pressure at specific times, which may not capture important changes. The goal of this trial is to compare the eye pressure readings from the new sensing contact lens with those from traditional tonometry in patients diagnosed with open-angle glaucoma or ocular hypertension.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of either primary open-angle glaucoma or ocular hypertension. They should also have open angles in their eyes and meet specific measurements regarding their cornea. Participants will wear the sensing contact lens for 24 hours to collect data on their eye pressure while going about their daily activities. It’s important to note that people with certain eye conditions, previous eye surgeries, or specific health issues may not qualify for the study. This trial is not yet recruiting participants, but it aims to improve the way we monitor eye pressure in glaucoma patients, helping to manage their condition more effectively.

Gender

ALL

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.