Rebound Esthesiometer Phase 2 Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Corneal Sensation Reduced
- Sponsor
- Icare Finland Oy
- Enrollment
- 100
- Primary Endpoint
- Rebound esthesiometer operating parameters
- Last Updated
- 5 years ago
Overview
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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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.