Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sensing Contact Lens-based Device for 24-hour Monitoring of Intraocular Pressure

NCT03689088

Glaucoma, Open-Angle Healthy

COMPLETED NA

24h Continuous Intraocular Pressure (IOP) Monitoring vs Goldmann Applanation Tonometry

NCT01217853

Primary Open Angle Glaucoma

COMPLETED

Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

NCT01849536

Open Angle Glaucoma With a Progressive Visual Field

COMPLETED NA

Prospective, Open Label Study to Assess 24hs IOP Recorded With Triggerfish® in Patients With OAG Before and After DSCI

NCT05876936

Open Angle Glaucoma

TERMINATED NA

Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor

NCT01390779

Primary Open Angle Glaucoma Healthy Subjects

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All participants

All patients will be follow the same procedures and be placed the investigational device

Group Type EXPERIMENTAL

Goldfish (GF)

Intervention Type DEVICE

The GF lens (SCL) will be place on participant's eye for a 24h IOP recording session

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Goldfish (GF)

The GF lens (SCL) will be place on participant's eye for a 24h IOP recording session

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No