Defining the Operating Parameters for a Rebound-esthesiometer

Icare

Status

Unknown

Conditions

Corneal Sensation Reduced

Corneal Transplant Failure

Herpetic Keratitis

Corneal Degeneration

Corneal Dystrophy

Treatments

Device: Esthesiometer measurement

Study type

Observational

Funder types

Industry

Identifiers

NCT04384094

TE0X_EST_2

Details and patient eligibility

About

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

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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.