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The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.
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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test subjects | Test subjects according to the inclusion / exclusion criterias. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esthesiometer measurement | Device | Measuring the corneal sensitivity using rebound technology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rebound esthesiometer operating threshold | 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. | 2020-2021 |
| Rebound esthesiometer operating parameters | 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. | 2020-2021 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mika Salkola, M.Sc. | Contact | +358400874054 | mika.salkola@icarefinland.com | |
| Teemu Herranen, B.Sc. | Contact | +358415033680 | teemu.herranen@icarefinland.com |
| Name | Affiliation | Role |
|---|---|---|
| Matjaz Mihelcic, Ph.D. | Optika Mesec | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 29, 2021 | |
| Reset | Apr 23, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 29, 2021 | Apr 23, 2021 |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D016849 | Keratitis, Herpetic |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
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| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007634 | Keratitis |