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Defining the Operating Parameters for a Rebound-esthesiometer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04384094
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : July 29, 2020
Information provided by (Responsible Party):
Icare Finland Oy

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

Condition or disease Intervention/treatment
Corneal Sensation Reduced Corneal Dystrophy Corneal Degeneration Corneal Transplant Failure Herpetic Keratitis Device: Esthesiometer measurement

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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Rebound Esthesiometer Phase 2 Protocol
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Test subjects
Test subjects according to the inclusion / exclusion criterias.
Device: Esthesiometer measurement
Measuring the corneal sensitivity using rebound technology.

Primary Outcome Measures :
  1. Rebound esthesiometer operating threshold [ Time Frame: 2020-2021 ]
    Define 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.

  2. Rebound esthesiometer operating parameters [ Time Frame: 2020-2021 ]
    Measure 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04384094

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Contact: Mika Salkola, M.Sc. +358400874054
Contact: Teemu Herranen, B.Sc. +358415033680

Sponsors and Collaborators
Icare Finland Oy
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Principal Investigator: Matjaz Mihelcic, Ph.D. Optika Mesec
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Responsible Party: Icare Finland Oy Identifier: NCT04384094    
Other Study ID Numbers: TE0X_EST_2
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icare Finland Oy:
corneal sensitivity
Additional relevant MeSH terms:
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Keratitis, Herpetic
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Eye Infections, Viral
Eye Infections
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases