<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/NCT04434521</url>
  </required_header>
  <id_info>
    <org_study_id>2019PBMD04</org_study_id>
    <secondary_id>2020-A00259-30</secondary_id>
    <nct_id>NCT04434521</nct_id>
  </id_info>
  <brief_title>Comparison of Different Refraction Measurements in Adults</brief_title>
  <acronym>REFRACT</acronym>
  <official_title>Comparison of Different Refraction Measurements in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Direction Centrale du Service de Santé des Armées</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Direction Centrale du Service de Santé des Armées</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The combatant is likely to carry out missions any time, any place, day or night. The very&#xD;
      strong degradation of natural vision performance in these conditions justifies the use of&#xD;
      visual replacement means, based on optronic sensors whose sensitivity is more adapted to&#xD;
      these luminous environments than that of the human eye.&#xD;
&#xD;
      The duration and repetition of missions carried out with night vision sensors lead to visual&#xD;
      complaints from users.&#xD;
&#xD;
      The literature on night vision binoculars adjustment states that a binocular adjustment of&#xD;
      the equipment provides more convex settings. The latter would then limit the strain on the&#xD;
      accommodative component, which is one of the possible sources of operator visual fatigue. In&#xD;
      order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the&#xD;
      refraction (optical defect of the eye) of each operator. Like binocular adjustments,&#xD;
      binocular refractive methods would limit accommodative stimulation and thus visual fatigue.&#xD;
      However, these methods are little used in favour of conventional methods. It is therefore&#xD;
      necessary to evaluate the interest of binocular refraction for the adjustment of night vision&#xD;
      binoculars.&#xD;
&#xD;
      The purpose of this study is to compare refraction measurements by procedure in adult&#xD;
      subjects free of ophthalmological disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2021</start_date>
  <completion_date type="Actual">May 3, 2021</completion_date>
  <primary_completion_date type="Actual">May 3, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum convex equivalent sphere values</measure>
    <time_frame>At visit 1 (day 1)</time_frame>
    <description>Maximum convex equivalent sphere values obtained by the different refraction procedures under study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High contrast monocular acuity values</measure>
    <time_frame>At visit 1 (day 1)</time_frame>
    <description>High contrast monocular acuity values obtained by the different refraction procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low contrast monocular acuity values</measure>
    <time_frame>At visit 1 (day 1)</time_frame>
    <description>Low contrast monocular acuity values obtained by the different refraction procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High contrast binocular acuity values</measure>
    <time_frame>At visit 1 (day 1)</time_frame>
    <description>High contrast binocular acuity values obtained by the different refraction procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low contrast binocular acuity values</measure>
    <time_frame>At visit 1 (day 1)</time_frame>
    <description>Low contrast binocular acuity values obtained by the different refraction procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between binocular perceptual assessment scores before and after subjective adjustment</measure>
    <time_frame>Difference between visit 1 (day 1) and visit 2</time_frame>
    <description>Difference between binocular perceptual assessment scores obtained by the different refractive procedures before and after subjective adjustment.&#xD;
Binocular perceptual assessment score will be obtained using visual analogue faces. The score will range from &quot;excellent comfort&quot; to &quot;unbearable&quot;.</description>
  </secondary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Vision Loss Night</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire about habits in terms of near vision activities</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eye examination</intervention_name>
    <description>The eye examination involves the following measurements:&#xD;
Distant vision phoria with Thorington method&#xD;
Close vision with Thorington method&#xD;
Objective eye-to-eye refraction with self-refractometer&#xD;
Binocular objective refraction with autorefractometer&#xD;
Monocular/biocular/binocular refraction with Nidek TS610&#xD;
SiView automatic refraction&#xD;
Humphriss binocular refraction&#xD;
MOU Binocular refraction</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 ;&#xD;
&#xD;
          -  Non-presbyopic subject;&#xD;
&#xD;
          -  Stereoscopic acuity ≤ 60 arc seconds.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Accommodative insufficiency;&#xD;
&#xD;
          -  Accommodative inertia;&#xD;
&#xD;
          -  Compensation by orthokeratology (i.e. night lenses);&#xD;
&#xD;
          -  Present or past binocular pathology (strabismus or amblyopia);&#xD;
&#xD;
          -  Pregnant or nursing woman;&#xD;
&#xD;
          -  Incomprehension of French (written and spoken).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut de Recherche Biomédicale des Armées</name>
      <address>
        <city>Brétigny-sur-Orge</city>
        <zip>91223</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Night Blindness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04434521
org study id: 2019PBMD04
secondary id: 2020-A00259-30
nct id: NCT04434521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The combatant is likely to carry out missions any time, any place, day or night. The very
      strong degradation of natural vision performance in these conditions justifies the use of
      visual replacement means, based on optronic sensors whose sensitivity is more adapted to
      these luminous environments than that of the human eye.

      The duration and repetition of missions carried out with night vision sensors lead to visual
      complaints from users.

      The literature on night vision binoculars adjustment states that a binocular adjustment of
      the equipment provides more convex settings. The latter would then limit the strain on the
      accommodative component, which is one of the possible sources of operator visual fatigue. In
      order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the
      refraction (optical defect of the eye) of each operator. Like binocular adjustments,
      binocular refractive methods would limit accommodative stimulation and thus visual fatigue.
      However, these methods are little used in favour of conventional methods. It is therefore
      necessary to evaluate the interest of binocular refraction for the adjustment of night vision
      binoculars.

      The purpose of this study is to compare refraction measurements by procedure in adult
      subjects free of ophthalmological disorders.
observational model: Cohort
time perspective: Prospective
measure: Maximum convex equivalent sphere values
time frame: At visit 1 (day 1)
description: Maximum convex equivalent sphere values obtained by the different refraction procedures under study.
measure: High contrast monocular acuity values
time frame: At visit 1 (day 1)
description: High contrast monocular acuity values obtained by the different refraction procedures.
measure: Low contrast monocular acuity values
time frame: At visit 1 (day 1)
description: Low contrast monocular acuity values obtained by the different refraction procedures.
measure: High contrast binocular acuity values
time frame: At visit 1 (day 1)
description: High contrast binocular acuity values obtained by the different refraction procedures.
measure: Low contrast binocular acuity values
time frame: At visit 1 (day 1)
description: Low contrast binocular acuity values obtained by the different refraction procedures.
measure: Difference between binocular perceptual assessment scores before and after subjective adjustment
time frame: Difference between visit 1 (day 1) and visit 2
description: Difference between binocular perceptual assessment scores obtained by the different refractive procedures before and after subjective adjustment.
Binocular perceptual assessment score will be obtained using visual analogue faces. The score will range from "excellent comfort" to "unbearable".
intervention type: Behavioral
intervention name: Questionnaire
description: Questionnaire about habits in terms of near vision activities
intervention type: Other
intervention name: Eye examination
description: The eye examination involves the following measurements:
Distant vision phoria with Thorington method
Close vision with Thorington method
Objective eye-to-eye refraction with self-refractometer
Binocular objective refraction with autorefractometer
Monocular/biocular/binocular refraction with Nidek TS610
SiView automatic refraction
Humphriss binocular refraction
MOU Binocular refraction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Night Blindness
sharing ipd: Undecided