<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/NCT02198534</url>
  </required_header>
  <id_info>
    <org_study_id>F-2014-049</org_study_id>
    <nct_id>NCT02198534</nct_id>
  </id_info>
  <brief_title>Comparison of the Freiburg Visual Acuity Test (FrACT) With the EDTRS- and Landoltring Charts</brief_title>
  <acronym>FEL</acronym>
  <official_title>Comparison of the Freiburg Visual Acuity Test (FrACT) With the EDTRS- and Landoltring Charts: a) Assessment of the Inter-test Agreement and the Test-retest Reliability b) Analysis of Examinees' / Examiner's Subjective Rating and of Test Durations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schiefer Ulrich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A) For the investigation of Visual acuity, inter-test agreement and the test-retest&#xD;
      reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart&#xD;
      and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice&#xD;
      but the sequence of the visual acuity tests were randomize and so different for each&#xD;
      examinee. The examinees were 24 adult Aalen university students (except students of&#xD;
      ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with&#xD;
      correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a&#xD;
      maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C&#xD;
      was projected in eight-orientations. For the FrACT Test we used two different devices for&#xD;
      response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt&#xD;
      device with an adjustable Landoltring (FrACTh). The primary objective was the comparison&#xD;
      between FrACTk and FrACTh. The secondary Objective contains the comparison between all visual&#xD;
      acuity tests.&#xD;
&#xD;
      B) Background: Landolt Cs and letters are commonly used optotypes. In the explorative study&#xD;
      we compare four different ways of applying them: The Freiburg visual acuity test (FrACT)&#xD;
      using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and&#xD;
      DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to&#xD;
      determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the&#xD;
      inter-test agreement between the tests and test-retest reliability of the tests, concerning&#xD;
      the test duration.&#xD;
&#xD;
      Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were included&#xD;
      in the explorative study. The visual acuity of one eye was measured monocularly, randomized&#xD;
      with regard to the leading/non-leading eye. The subjects passed every visual acuity test&#xD;
      twice in a randomized sequence of the visual acuity tests, which is maintained by a&#xD;
      pre-specified randomization list, making use of forced choice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. FrACT (internet version 3.8.1) 1.1 haptic Landolt Ring device (FrACTh) 1.2 modified&#xD;
           keypad with Landolt Ring symbols (FrACTk)&#xD;
&#xD;
        2. ETDRS Visual Acuity Tester (Steinbeis Transferzentrum Biomedizinische Optik,&#xD;
           Tübingen/Germany)&#xD;
&#xD;
        3. Landoltring chart (Visus GmbH, Stuttgart/Germany)&#xD;
&#xD;
        4. VISUCAT monitor with single optotype display(numbers; Argus Individuell Optic GmbG,&#xD;
           Putzbrunn/Germany)&#xD;
&#xD;
        5. Room illuminance level 250 lx, assessed with digital luxmeter (Peak Tech 5025, Peak Tech&#xD;
           Prüf - und Messtechnik GmbH, Ahrensburg/Germany)&#xD;
&#xD;
        6. Laptopdisplay (TravelMate, Acer, 8372 Taipeh/China):&#xD;
&#xD;
           luminance level 151 cd/m2 , surround luminance level 75 cd/m2 , assessed with luminance&#xD;
           meter (IS-110 Laptop Minolta, Tokyo/Japan)&#xD;
&#xD;
        7. ETDRS Visual Acuity Tester:&#xD;
&#xD;
           luminance level: 237 cd/m², surround luminance level 85 cd/m²&#xD;
&#xD;
        8. Landoltring Chart:&#xD;
&#xD;
           luminance level: 236 cd/m², surround luminance level 84 cd/m²&#xD;
&#xD;
        9. VISUCAT:&#xD;
&#xD;
           luminance level: 380 cd/m², surround luminance level 70 cd/m²&#xD;
&#xD;
       10. Stopwatch (Apple iPhone 4S, Cupertino CA/USA)&#xD;
&#xD;
       11. Laser Rangefinder (GLM 80 Professional, Bosch GmbH, Stuttgart/Germany)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>A) 1.Visual acuity (in terms of spatial resolution)</measure>
    <time_frame>July - August, 2014 (1 month)</time_frame>
    <description>Comparison of visual acuity measurements, visualized by Bland-Altman plots</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-test agreement between FrACTh and FrACTk with regard to visual acuity results</measure>
    <time_frame>July - August, 2014 (1 month)</time_frame>
    <description>Assessment of inter-test agreement between FrACTh and FrACTk by comparison between these two methods, visualized by Bland-Altman plots</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test-retest reliability of FrACTh and FrACTk with regard to visual acuity results</measure>
    <time_frame>July - August, 2014 (1 month)</time_frame>
    <description>Assessment of test-retest reliability of FrACTh and FrACTk by repeated measurements, visualized by Bland-Altman plots</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examinees´ / examer's subjective ratings regarding the test procedures</measure>
    <time_frame>July - August, 2014 (1 month)</time_frame>
    <description>Assessment of examinees´ / examiner´s subjective ratings, using box &amp; whisker plots for analysis of the visual analogue scale (VAS) results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test duration (in seconds)</measure>
    <time_frame>July - August, 2014 (1 month)</time_frame>
    <description>Assessment of test duration and its comparison, using box &amp; whisker plots and/or Bland-Altman plots</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Ophthalmologically Normal Subjects</condition>
  <arm_group>
    <arm_group_label>ophthalomogically normal subjects</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Methodology of visual acuity assessment</intervention_name>
    <arm_group_label>ophthalomogically normal subjects</arm_group_label>
    <other_name>VISUCAT</other_name>
    <other_name>FrACT</other_name>
    <other_name>ETDRS Chart</other_name>
    <other_name>Landolt C</other_name>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      None applicable&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Ophthalmologically normal subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  Minimum distant visual acuity (without/with correction) 0.2 (Visucat, single letter&#xD;
             optotypes [numbers], initial session). As long as minimum distant visual acuity limits&#xD;
             are exceeded, test runs without optical corrections are preferred in order to enhance&#xD;
             the spectrum/variety of tested visual acuity values&#xD;
&#xD;
          -  Ametropia:&#xD;
&#xD;
        maximum myopia sph -2.00 dpt maximum hyperopia sph +5.50 dpt maximum astigmatism cyl 2.5&#xD;
        dpt&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy / psychiatric disorders&#xD;
&#xD;
          -  Drugs affect the reaction time and / or determining the visual acuity, or the&#xD;
             refractive power of the eye&#xD;
&#xD;
          -  Ophthalmic Education&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  strabismus&#xD;
&#xD;
          -  Glaucoma IOP&gt; 22 mmHg&#xD;
&#xD;
          -  Nystagmus&#xD;
&#xD;
          -  Diabetic retinopathy (blood sugar-related retinal disease)&#xD;
&#xD;
          -  Very dry eyes (sicca symptoms)&#xD;
&#xD;
          -  eye surgery back are less than 3 months&#xD;
&#xD;
          -  Infectious diseases (conjunctivitis, corneal inflammation, choroidal inflammation)&#xD;
&#xD;
          -  miosis drugs&#xD;
&#xD;
          -  Pronounced eye injuries&#xD;
&#xD;
          -  Other eye disorders that affect the image quality&#xD;
&#xD;
          -  Macular diseases&#xD;
&#xD;
          -  albinism&#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>
  <overall_official>
    <last_name>Ulrich Schiefer, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Applied Sciences Aalen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Applied Sciences, Study Course Ophthalmic Optics</name>
      <address>
        <city>Aalen</city>
        <state>Baden-Württemberg</state>
        <zip>73430</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aalen University</investigator_affiliation>
    <investigator_full_name>Schiefer Ulrich</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>visual acuity</keyword>
  <keyword>Landolt C</keyword>
  <keyword>ETDRS charts</keyword>
  <keyword>Freiburg Visual Acuity Test</keyword>
  <keyword>FrACT</keyword>
  <keyword>Comparison</keyword>
  <keyword>acceptance</keyword>
  <keyword>Test retest reliability</keyword>
  <keyword>duration</keyword>
  <keyword>questionnaire</keyword>
  <!-- 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/NCT02198534
org study id: F-2014-049
nct id: NCT02198534
lead sponsor: 
has dmc: No
A) For the investigation of Visual acuity, inter-test agreement and the test-retest
      reliability were used three different visual acuity tests: ETDRS charts, Landoltring chart
      and Freiburg Visual Acuity Test (FrACt). The examinees passed each visual acuity test twice
      but the sequence of the visual acuity tests were randomize and so different for each
      examinee. The examinees were 24 adult Aalen university students (except students of
      ophthalmic optics in terms 2 - 7) with a minimal distant visual acuity without or with
      correction of 0.2. Another inclusion criteria was a maximum myopia of sph -2,00 dpt, a
      maximum hyperopia of sph +5,50 dpt and a maximum astigmatism of cyl 2,50 dpt. The Landolt C
      was projected in eight-orientations. For the FrACT Test we used two different devices for
      response input: a modified keypad with Landoltring symbols (FrACTk) and a haptic Landolt
      device with an adjustable Landoltring (FrACTh). The primary objective was the comparison
      between FrACTk and FrACTh. The secondary Objective contains the comparison between all visual
      acuity tests.

      B) Background: Landolt Cs and letters are commonly used optotypes. In the explorative study
      we compare four different ways of applying them: The Freiburg visual acuity test (FrACT)
      using a keypad and a haptic Landolt device, a Landolt C chart in accordance to ISO 8596 and
      DIN 58220 with eight-orientated Landolt C and ETDRS charts. The aims of the survey were to
      determine examinee´s/examiner´s subjective ratings using Visual analogue scales (VAS), the
      inter-test agreement between the tests and test-retest reliability of the tests, concerning
      the test duration.

      Subjects and Methods: Twenty-four adult examinees with a visual acuity of ≥ 0,2 were included
      in the explorative study. The visual acuity of one eye was measured monocularly, randomized
      with regard to the leading/non-leading eye. The subjects passed every visual acuity test
      twice in a randomized sequence of the visual acuity tests, which is maintained by a
      pre-specified randomization list, making use of forced choice.
1. FrACT (internet version 3.8.1) 1.1 haptic Landolt Ring device (FrACTh) 1.2 modified
           keypad with Landolt Ring symbols (FrACTk)

        2. ETDRS Visual Acuity Tester (Steinbeis Transferzentrum Biomedizinische Optik,
           Tübingen/Germany)

        3. Landoltring chart (Visus GmbH, Stuttgart/Germany)

        4. VISUCAT monitor with single optotype display(numbers; Argus Individuell Optic GmbG,
           Putzbrunn/Germany)

        5. Room illuminance level 250 lx, assessed with digital luxmeter (Peak Tech 5025, Peak Tech
           Prüf - und Messtechnik GmbH, Ahrensburg/Germany)

        6. Laptopdisplay (TravelMate, Acer, 8372 Taipeh/China):

           luminance level 151 cd/m2 , surround luminance level 75 cd/m2 , assessed with luminance
           meter (IS-110 Laptop Minolta, Tokyo/Japan)

        7. ETDRS Visual Acuity Tester:

           luminance level: 237 cd/m², surround luminance level 85 cd/m²

        8. Landoltring Chart:

           luminance level: 236 cd/m², surround luminance level 84 cd/m²

        9. VISUCAT:

           luminance level: 380 cd/m², surround luminance level 70 cd/m²

       10. Stopwatch (Apple iPhone 4S, Cupertino CA/USA)

       11. Laser Rangefinder (GLM 80 Professional, Bosch GmbH, Stuttgart/Germany)
observational model: Cohort
time perspective: Prospective
measure: A) 1.Visual acuity (in terms of spatial resolution)
time frame: July - August, 2014 (1 month)
description: Comparison of visual acuity measurements, visualized by Bland-Altman plots
measure: Inter-test agreement between FrACTh and FrACTk with regard to visual acuity results
time frame: July - August, 2014 (1 month)
description: Assessment of inter-test agreement between FrACTh and FrACTk by comparison between these two methods, visualized by Bland-Altman plots
measure: Test-retest reliability of FrACTh and FrACTk with regard to visual acuity results
time frame: July - August, 2014 (1 month)
description: Assessment of test-retest reliability of FrACTh and FrACTk by repeated measurements, visualized by Bland-Altman plots
measure: Examinees´ / examer's subjective ratings regarding the test procedures
time frame: July - August, 2014 (1 month)
description: Assessment of examinees´ / examiner´s subjective ratings, using box & whisker plots for analysis of the visual analogue scale (VAS) results
measure: Test duration (in seconds)
time frame: July - August, 2014 (1 month)
description: Assessment of test duration and its comparison, using box & whisker plots and/or Bland-Altman plots
arm group label: ophthalomogically normal subjects
intervention type: Device
intervention name: Methodology of visual acuity assessment
arm group label: ophthalomogically normal subjects
other name: VISUCAT
other name: FrACT
other name: ETDRS Chart
other name: Landolt C
None applicable
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ulrich Schiefer, Prof. Dr. med.
role: Principal Investigator
affiliation: University of Applied Sciences Aalen
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Aalen University
investigator full name: Schiefer Ulrich
investigator title: Prof. Dr. med.