Defining the Operating Parameters for a Rebound-esthesiometer

NCT ID: NCT04384094

Last Updated: 2020-07-29

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

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Test subjects

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Esthesiometer measurement

Intervention Type DEVICE

Measuring the corneal sensitivity using rebound technology.

Interventions

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Esthesiometer measurement

Measuring the corneal sensitivity using rebound technology.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icare Finland Oy

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matjaz Mihelcic, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Optika Mesec

Central Contacts

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Mika Salkola, M.Sc.

Role: CONTACT

+358400874054

Teemu Herranen, B.Sc.

Role: CONTACT

+358415033680

Other Identifiers

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TE0X_EST_2

Identifier Type: -

Identifier Source: org_study_id

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