Validation of a Newly Developed Liquid Jet Aesthesiometer

Sponsor
University of Applied Sciences and Arts Northwestern Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT02999035
Collaborator
(none)
60
5

Study Details

Study Description

Brief Summary

A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular surface sensitivity by employing a liquid jet.

This study aims to validate this new prototype by means of correlating its measurement with a previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Currently, no aesthesiometer is available that delivers reliable and repeatable measurement of ocular surface sensitivity in a routine clinical setup. The only commercially available Cochet- Bonnet aesthesiometer uses a tactile-mechanical stimulus (the tip of a nylon thread), which can cause a microerosion when applied to the corneal surface. Additional disadvantages represent poor stimulus reproducibility, a limited stimulus bandwidth and the influence of humidity and age on the bending capibility of the nylon thread. For research purposes prototypes of non-contact air aesthesiometers (eg by Murphy et al. and Belmonte et al) are being used.

    This study aims to correlate ocular surface sensitivity measurements of a newly developed prototype, the liquid jet aesthesiometer, with the non-contact air jet aesthesiometer by Murphy et al. 1996 and to explore its repeatability of measurement.

    In this repeated measures design 60 subjects participate in corneal sensitivity measurements during two appointments with each described aesthesiometer.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Validation of a Newly Developed Liquid Jet Aesthesiometer
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    corneal sensitivity measurement

    Air jet aesthesiometry and liquid jet aesthesiometry: All patients will receive the same intervention of corneal sensitivity measurement with air jet aesthesiometry and liquid jet aesthesiometry. Thresholds represent the intensity of air / liquid jet that can just be perceived by the patients.

    Outcome Measures

    Primary Outcome Measures

    1. Correlation with air jet aesthesiometry [two measurements / repeated measures within one month]

      correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry

    Secondary Outcome Measures

    1. repeatability of corneal sensitivity measurement with new prototype [two measurements / repeated measures within one month]

      repeatability of corneal sensitivity measurement with liquid jet aesthesiometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Ocular surface index score < 13.0
    Exclusion Criteria:
    • systemic disease such as diabetes, diseases, injuries and operations in the anterior segment of the eye

    • systemic medication and / or eyedrops / ointments that may have an influence of the tearfilm.

    • contact lens wear less than 48 hours before commencement of study measurements.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Applied Sciences and Arts Northwestern Switzerland

    Investigators

    • Principal Investigator: Remo Poffa, MSc., University of Applied Sciences and Arts Northwestern Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Remo Poffa, Study coordinator, University of Applied Sciences and Arts Northwestern Switzerland
    ClinicalTrials.gov Identifier:
    NCT02999035
    Other Study ID Numbers:
    • 2016-01867
    First Posted:
    Dec 21, 2016
    Last Update Posted:
    Aug 24, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Remo Poffa, Study coordinator, University of Applied Sciences and Arts Northwestern Switzerland

    Study Results

    No Results Posted as of Aug 24, 2017