<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999035</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01867</org_study_id>
    <nct_id>NCT02999035</nct_id>
  </id_info>
  <brief_title>Validation of a Newly Developed Liquid Jet Aesthesiometer</brief_title>
  <official_title>Validation of a Newly Developed Liquid Jet Aesthesiometer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Applied Sciences and Arts Northwestern Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Applied Sciences and Arts Northwestern Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular&#xD;
      surface sensitivity by employing a liquid jet.&#xD;
&#xD;
      This study aims to validate this new prototype by means of correlating its measurement with a&#xD;
      previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy&#xD;
      et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, no aesthesiometer is available that delivers reliable and repeatable measurement&#xD;
      of ocular surface sensitivity in a routine clinical setup. The only commercially available&#xD;
      Cochet- Bonnet aesthesiometer uses a tactile-mechanical stimulus (the tip of a nylon thread),&#xD;
      which can cause a microerosion when applied to the corneal surface. Additional disadvantages&#xD;
      represent poor stimulus reproducibility, a limited stimulus bandwidth and the influence of&#xD;
      humidity and age on the bending capibility of the nylon thread. For research purposes&#xD;
      prototypes of non-contact air aesthesiometers (eg by Murphy et al. and Belmonte et al) are&#xD;
      being used.&#xD;
&#xD;
      This study aims to correlate ocular surface sensitivity measurements of a newly developed&#xD;
      prototype, the liquid jet aesthesiometer, with the non-contact air jet aesthesiometer by&#xD;
      Murphy et al. 1996 and to explore its repeatability of measurement.&#xD;
&#xD;
      In this repeated measures design 60 subjects participate in corneal sensitivity measurements&#xD;
      during two appointments with each described aesthesiometer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation with air jet aesthesiometry</measure>
    <time_frame>two measurements / repeated measures within one month</time_frame>
    <description>correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>repeatability of corneal sensitivity measurement with new prototype</measure>
    <time_frame>two measurements / repeated measures within one month</time_frame>
    <description>repeatability of corneal sensitivity measurement with liquid jet aesthesiometry</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ocular Surface Disease</condition>
  <arm_group>
    <arm_group_label>corneal sensitivity measurement</arm_group_label>
    <description>Air jet aesthesiometry and liquid jet aesthesiometry:&#xD;
All patients will receive the same intervention of corneal sensitivity measurement with air jet aesthesiometry and liquid jet aesthesiometry.&#xD;
Thresholds represent the intensity of air / liquid jet that can just be perceived by the patients.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        30 healthy subjects within age range of 18-30 years 30 healthy subjects within age range of&#xD;
        50-65 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ocular surface index score &lt; 13.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic disease such as diabetes, diseases, injuries and operations in the anterior&#xD;
             segment of the eye&#xD;
&#xD;
          -  systemic medication and / or eyedrops / ointments that may have an influence of the&#xD;
             tearfilm.&#xD;
&#xD;
          -  contact lens wear less than 48 hours before commencement of study measurements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Remo Poffa, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Applied Sciences and Arts Northwestern Switzerland</affiliation>
  </overall_official>
  <reference>
    <citation>Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.</citation>
    <PMID>8762770</PMID>
  </reference>
  <reference>
    <citation>COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.</citation>
    <PMID>13880071</PMID>
  </reference>
  <reference>
    <citation>Belmonte C, Acosta MC, Schmelz M, Gallar J. Measurement of corneal sensitivity to mechanical and chemical stimulation with a CO2 esthesiometer. Invest Ophthalmol Vis Sci. 1999 Feb;40(2):513-9.</citation>
    <PMID>9950612</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Applied Sciences and Arts Northwestern Switzerland</investigator_affiliation>
    <investigator_full_name>Remo Poffa</investigator_full_name>
    <investigator_title>Study coordinator</investigator_title>
  </responsible_party>
  <keyword>ocular surface sensitivity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>individual participant data will not be made available to other researchers. The statistical analysis of the data overall will be however published, but individual participant data will not be discussed.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999035
org study id: 2016-01867
nct id: NCT02999035
lead sponsor: 
has dmc: No
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.
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.
observational model: Other
time perspective: Other
measure: Correlation with air jet aesthesiometry
time frame: two measurements / repeated measures within one month
description: correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry
measure: repeatability of corneal sensitivity measurement with new prototype
time frame: two measurements / repeated measures within one month
description: repeatability of corneal sensitivity measurement with liquid jet aesthesiometry
arm group label: corneal sensitivity measurement
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Remo Poffa, MSc.
role: Principal Investigator
affiliation: University of Applied Sciences and Arts Northwestern Switzerland
citation: Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.
PMID: 8762770
citation: COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.
PMID: 13880071
citation: Belmonte C, Acosta MC, Schmelz M, Gallar J. Measurement of corneal sensitivity to mechanical and chemical stimulation with a CO2 esthesiometer. Invest Ophthalmol Vis Sci. 1999 Feb;40(2):513-9.
PMID: 9950612
responsible party type: Principal Investigator
investigator affiliation: University of Applied Sciences and Arts Northwestern Switzerland
investigator full name: Remo Poffa
investigator title: Study coordinator
sharing ipd: No
ipd description: individual participant data will not be made available to other researchers. The statistical analysis of the data overall will be however published, but individual participant data will not be discussed.