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Defining the Operating Parameters for a Rebound-esthesiometer

Rebound Esthesiometer Phase 2 Protocol

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04384094
Enrollment
100
Registered
2020-05-12
Start date
2020-08-31
Completion date
2020-12-31
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Degeneration, Corneal Dystrophy, Corneal Sensation Reduced, Corneal Transplant Failure, Herpetic Keratitis

Keywords

esthesiometry, corneal sensitivity

Brief summary

The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.

Detailed description

Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients. In this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.

Interventions

DEVICEEsthesiometer measurement

Measuring the corneal sensitivity using rebound technology.

Sponsors

Icare Finland Oy
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \>= 18 * Informed consent signed

Exclusion criteria

* Signs of infectious or inflammatory disease of anterior eye at the time of presentation. * During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event. * Unable to give informed consent. * Directly or indirectly indicated vunerability.

Design outcomes

Primary

MeasureTime frameDescription
Rebound esthesiometer operating threshold2020-2021Define the corneal touch sensitivity threshold using the rebound esthesiometer by varying the measurement probe impact at the moment of touch of corneal surface. The impact is varied by changing the speed (m/s) of the measurement probe and the subjective sensation of the test subject is recorded. The mass (mg) of the measurement probe is known and the impact energy is calculated.
Rebound esthesiometer operating parameters2020-2021Measure the correlation of corneal touch sensitivity between rebound esthesiometer and the reference instrument Cochet-Bonnet monofilament esthesiometer. With the rebound esthesiometer the impact is varied by changing the speed (m/s) of the measurement probe. The probe mass (mg) and speed (m/s) equals to the touch impact impulse which causes the touch sensation. The subjective sensation of the test subject is recorded.

Contacts

Primary ContactMika Salkola, M.Sc.
mika.salkola@icarefinland.com+358400874054
Backup ContactTeemu Herranen, B.Sc.
teemu.herranen@icarefinland.com+358415033680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026