Corneal Dystrophy Clinical Trial
Official title:
Rebound Esthesiometer Phase 2 Protocol
The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Icare Finland Oy |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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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