Defining the Operating Parameters for a Rebound-esthesiometer

Corneal Dystrophy Clinical Trial

Official title:

Rebound Esthesiometer Phase 2 Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04384094
• Other study ID #: TE0X_EST_2
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Icare Finland Oy
• Contact: Mika Salkola, M.Sc.
• Phone: +358400874054
• Email: mika.salkola[@]icarefinland.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Corneal Degeneration
• Corneal Dystrophy
• Corneal Sensation Reduced
• Corneal Transplant Failure
• Herpetic Keratitis
• Keratitis
• Keratitis, Herpetic

Intervention

Device:
• Esthesiometer measurement
Measuring the corneal sensitivity using rebound technology.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Icare Finland Oy

Outcome

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