Defining the Operating Parameters for a Rebound-esthesiometer

• Conditions: Corneal Sensation Reduced; Corneal Dystrophy; Herpetic Keratitis; Corneal Degeneration; Corneal Transplant Failure
• Interventions: Device: Esthesiometer measurement

• Registration Number: NCT04384094
• Lead Sponsor: Icare Finland Oy

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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29
• Study Start: 2020-08
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test subjects	Esthesiometer measurement	Test subjects according to the inclusion / exclusion criterias.

Primary Outcome Measures

Name	Time	Method
Rebound esthesiometer operating parameters	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	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.