<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/NCT03285204</url>
  </required_header>
  <id_info>
    <org_study_id>ELA-AF-OCT-2014-01</org_study_id>
    <nct_id>NCT03285204</nct_id>
  </id_info>
  <brief_title>Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia</brief_title>
  <official_title>Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jose Luis Urcelay Segura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</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 aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and&#xD;
      Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up&#xD;
      the patient with optic coherence tomography, a fast, non-invasive and comfortable method&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will be asked about their data and their general medical history, and will be&#xD;
      underwent on one hand, a complete neurological examination including the degree of&#xD;
      neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r)&#xD;
      or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a&#xD;
      complete ophthalmological examination too, including the patient's graduation, pupillary and&#xD;
      ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will&#xD;
      be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell&#xD;
      28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see&#xD;
      possible anatomical alterations in both macula and optic nerve. The follow-up of these&#xD;
      explorations will be repeated in all cases at 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia</measure>
    <time_frame>change from baseline to 6 month</time_frame>
    <description>macular, ganglion cell layer and retinal nerve fiber layer thickness measure</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>ALS patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Friedreich Ataxia patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Amyotrophic lateral sclerosis patients Friedreich's ataxia patients Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years.&#xD;
&#xD;
          -  Best corrected visual acuity more than 0.4 (20/50 Snellen = 0.4 logMAR = 65 ETDRS&#xD;
             letters).&#xD;
&#xD;
          -  Refractive defect less than 5 diopters of spherical equivalent and / or cylinder less&#xD;
             than 2 diopters.&#xD;
&#xD;
          -  Transparent optical media: Opacity of crystalline &lt;1 according to Lens Opacities&#xD;
             Classification System (LOCS) III.&#xD;
&#xD;
          -  Open anterior chamber angle assessed by gonioscopy with Goldmann lens (grade&gt; III).&#xD;
&#xD;
          -  Availability and collaboration to carry out the tests of the exploratory protocol.&#xD;
&#xD;
          -  Acceptance of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous intraocular surgeries of less than 6 months of evolution. Patients with&#xD;
             refractive surgery using the LASIK or LASEK technique will not be excluded.&#xD;
&#xD;
          -  Physical or mental difficulties to perform reliable and reproducible perimeters.&#xD;
&#xD;
          -  Pathology and / or ocular malformations, angular or optic nerve anomalies.&#xD;
&#xD;
          -  Any retinopathy or maculopathy.&#xD;
&#xD;
          -  Intraocular pressure (IOP)&gt; 21 mmHg.&#xD;
&#xD;
          -  Signal-to-noise ratio in OCT less than 5/10.&#xD;
&#xD;
          -  Failure to meet any inclusion criteria.&#xD;
&#xD;
          -  Mental retardation or any other limitation in obtaining informed consent.&#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>Jose L Urcelay, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HGU Gregorio Marañón</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pilar Rojas, MD</last_name>
    <phone>+34616042758</phone>
    <email>pilar.rojas.lozano@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pilar Rojas Lozano</name>
      <address>
        <city>Madrid</city>
        <zip>28010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pilar Rojas Lozano</last_name>
      <phone>+34616042758</phone>
      <email>pilar.rojas.lozano@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>March 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Jose Luis Urcelay Segura</investigator_full_name>
    <investigator_title>Head Of ophthalmology</investigator_title>
  </responsible_party>
  <keyword>optical coherence tomography</keyword>
  <keyword>amyotrophic lateral sclerosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
    <mesh_term>Friedreich Ataxia</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03285204
org study id: ELA-AF-OCT-2014-01
nct id: NCT03285204
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and
      Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up
      the patient with optic coherence tomography, a fast, non-invasive and comfortable method
All patients will be asked about their data and their general medical history, and will be
      underwent on one hand, a complete neurological examination including the degree of
      neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r)
      or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a
      complete ophthalmological examination too, including the patient's graduation, pupillary and
      ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will
      be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell
      28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see
      possible anatomical alterations in both macula and optic nerve. The follow-up of these
      explorations will be repeated in all cases at 6 months.
observational model: Case-Control
time perspective: Prospective
measure: early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia
time frame: change from baseline to 6 month
description: macular, ganglion cell layer and retinal nerve fiber layer thickness measure
arm group label: ALS patients
arm group label: Friedreich Ataxia patients
arm group label: Healthy control
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: Jose L Urcelay, PhD
role: Principal Investigator
affiliation: HGU Gregorio Marañón
last name: Pilar Rojas, MD
phone: +34616042758
email: pilar.rojas.lozano@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Jose Luis Urcelay Segura
investigator title: Head Of ophthalmology
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Vision Disorders
mesh term: Vision, Low
mesh term: Friedreich Ataxia
mesh term: Sclerosis
sharing ipd: No