Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry

Sponsor
Sensimed AG
Study ID
NCT04024293
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Jul 18, 2019
Start date
Oct 1, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: All participants
    All patients will be follow the same procedures and be placed the investigational device

Primary Outcome Measure

GF IOP measurement as compared to IOP [ Time Frame: 24 hours ]

Central Contacts

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