Defining the Operating Parameters for a Rebound-esthesiometer

NCT04384094 | Unknown

• 1 other identifier: TE0X_EST_2
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Corneal Sensation Reduced; Corneal Dystrophy; Corneal Degeneration; Corneal Transplant Failure; Herpetic Keratitis

Keywords

esthesiometry; corneal sensitivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Test subjects

Test subjects according to the inclusion / exclusion criterias.

Device: Esthesiometer measurement

Interventions

Esthesiometer measurement DEVICE

Measuring the corneal sensitivity using rebound technology.

Test subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.

You may qualify if:

• Age \>= 18
• Informed consent signed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icare Finland Oy: lead

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary; Keratitis, Herpetic

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis

Study Officials

• Matjaz Mihelcic, Ph.D.

  Optika Mesec

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mika Salkola, M.Sc.

CONTACT

+358400874054; mika.salkola@icarefinland.com

Teemu Herranen, B.Sc.

CONTACT

+358415033680; teemu.herranen@icarefinland.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 12, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share