Defining the Operating Parameters for a Rebound-esthesiometer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04384094|
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment|
|Corneal Sensation Reduced Corneal Dystrophy Corneal Degeneration Corneal Transplant Failure Herpetic Keratitis||Device: Esthesiometer measurement|
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 Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused.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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Rebound Esthesiometer Phase 2 Protocol|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Test subjects according to the inclusion / exclusion criterias.
Device: Esthesiometer measurement
Measuring the corneal sensitivity using rebound technology.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384094
|Contact: Mika Salkola, M.Sc.||+firstname.lastname@example.org|
|Contact: Teemu Herranen, B.Sc.||+email@example.com|
|Principal Investigator:||Matjaz Mihelcic, Ph.D.||Optika Mesec|