<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/NCT04448860</url>
  </required_header>
  <id_info>
    <org_study_id>P19-02</org_study_id>
    <secondary_id>2019-A00483-54</secondary_id>
    <nct_id>NCT04448860</nct_id>
  </id_info>
  <brief_title>Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities</brief_title>
  <acronym>PROST</acronym>
  <official_title>Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts</source>
  <oversight_info>
    <has_dmc>Yes</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 incidence of the disease of retinal degenerations with loss of photoreceptors (related to&#xD;
      old age or genetic) on patients' daily lives, is poorly characterize without standardized&#xD;
      means of measurement (usually performed with functional vision or reading tasks).&#xD;
&#xD;
      self-assessment by a quality of life questionnaire correlated with an assessment of emotional&#xD;
      state and direct observation of patients during daily life tasks are the two ways used in a&#xD;
      scientific framework to collect data on the difficulties encountered by patients in their&#xD;
      daily life.&#xD;
&#xD;
      The aim of this project is to determine the behavioral effects of retinitis pigmentosa (RP)&#xD;
      by the effects of performance reductions related to adapting to darkness and visual field&#xD;
      restriction. Those assessments will be in real conditions but also in virtual reality (VR).&#xD;
&#xD;
      This tool can be used to measure a therapeutic benefit for new treatments (like gene therapy,&#xD;
      retinal implants, intra vitreous injections …) for visual loss patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, longitudinal and non-randomized study will be conducted on 2 groups of&#xD;
      people: retinitis pigmentosa's patients ( 1st and 2nd phases) and healthy volunteers patients&#xD;
      (2nd phase).&#xD;
&#xD;
      The first phase's aim (named pilot phase) is to determine the optimal parameters to achieve&#xD;
      the locomotion test. Fifteen RP's eligible patients will be requiring to 4 sessions of 3&#xD;
      hours to perform tests (Two sessions on real conditions and the two others on virtual&#xD;
      reality).&#xD;
&#xD;
      The second phase's aim (named validation phase) is to validate tests to assess the impact of&#xD;
      peripheral visual impairment on the sensory and motor performance of patients in their daily&#xD;
      life. Firstly 15 RP's patients and 15 healthy volunteers will be included in this phase&#xD;
      conducted according to a plan of Simon. 21 additional patients will be including on each&#xD;
      group in view of the results on the first step in this 2nd phase.&#xD;
&#xD;
      For each patient, the duration of participation will be of 3 months for the first phase and&#xD;
      14 months for the second phase. The study duration is expected to be 50 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 4, 2019</start_date>
  <completion_date type="Anticipated">October 4, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 4, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>optimal Simon two-stage design</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pilot calibration phase in a real environment.</measure>
    <time_frame>Month 1</time_frame>
    <description>Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a real environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pilot calibration phase in a virtual environment.</measure>
    <time_frame>Month 1</time_frame>
    <description>Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a virtual environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validation phase on the motor performance</measure>
    <time_frame>Month 12</time_frame>
    <description>Validation of tests to assess the impact of peripheral visual impairment on the motor performance of patients in their daily life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validation phase on the sensory performance</measure>
    <time_frame>Month 12</time_frame>
    <description>Validation of tests to assess the impact of peripheral visual impairment on the sensory performance of patients in their daily life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validation of a locomotion test in virtual reality</measure>
    <time_frame>Day 1 - Month 1- Month 12</time_frame>
    <description>It is to validate the construction of the test and to determine its performance in discriminating nature, its reproducibility and its sensitivity to change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>Day1-Month 1- Month 12</time_frame>
    <description>Analyze the correlation between the results of patients' quality of life and the results of behavioral tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of the evolution of the postural parameters</measure>
    <time_frame>Day1 - Month 1 - Month 12</time_frame>
    <description>Evolution of postural's study parameters is performed by an experimental behavioral study, carried out during the same sessions as the main task of locomotion. The participants' postural stability will be correlated with the patient's visual parameters (acuity, visual field).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze the adverse events during the tasks' assessment</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Analyze the adverse events that will be collected during the performance of this study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">87</enrollment>
  <condition>Retinitis Pigmentosa</condition>
  <arm_group>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Retinitis Pigmentosa (RP) at different stages of impairment of the visual field, acuity and sensitivity to contrasts 15 patients will be included in phase 1 versus 36 in phase 2 (15 in step 1 and 21 in step 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>performance of behavioral locomotion tasks phase 1</intervention_name>
    <description>The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1)</description>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>performance of behavioral locomotion tasks phase 2</intervention_name>
    <description>The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)</description>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
    <arm_group_label>healthy volunteers patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender male or female&#xD;
&#xD;
          -  Non-syndromic pigmentary retinopathy: diagnosis confirmed by a specialist (RP&#xD;
             patients)&#xD;
&#xD;
          -  Pigmentary retinopathy with different damage's levels of visual field, acuity and&#xD;
             sensitivity to contrasts (RP patients)&#xD;
&#xD;
          -  Visual acuity of both corrected eyes (glasses, lenses) greater than or equal to 8/10&#xD;
             (or ≤ 0.1 logMAR) (Healthy volounteers)&#xD;
&#xD;
          -  Normal semi-automated kinetic visual field (Healthy volounteers)&#xD;
&#xD;
          -  Not participating in any other clinical trial that may interfere with this study&#xD;
&#xD;
          -  Sufficient knowledge of the French language to ensure understanding of the tasks to be&#xD;
             performed and the instructions received&#xD;
&#xD;
          -  Social insurance&#xD;
&#xD;
          -  Consent signed after information by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Inability to give personal consent&#xD;
&#xD;
          -  Cataract surgery in the 3 months before inclusion&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Inability to comply with the instructions for the study tasks or to complete the study&#xD;
             visits&#xD;
&#xD;
          -  MMSE score without visual item ≤ 20/25 for RP patients&#xD;
&#xD;
          -  MMSE score with visual item ≤ 25/30 for healthy volunteers&#xD;
&#xD;
          -  Drug treatment which may cause motor, visual or cognitive disorders (neuroleptics,&#xD;
             etc.) or which may interfere with study evaluations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saddek MOHAND-SAID, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre national d'ophtalmologique des 15-20</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tania RILCY</last_name>
    <phone>+33140021126</phone>
    <email>trilcy@15-20.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hayet SERHANE</last_name>
    <phone>+33140021144</phone>
    <email>hserhane@15-20.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre hospitalier national d'ophtalmologique de 15-20</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Saddek MOHAND-SAID, MD</last_name>
      <phone>01 40 02 14 30/31</phone>
      <email>smohand-said@15-20.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</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>Retinitis</mesh_term>
    <mesh_term>Retinitis Pigmentosa</mesh_term>
  </condition_browse>
  <!-- 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/NCT04448860
org study id: P19-02
secondary id: 2019-A00483-54
nct id: NCT04448860
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the incidence of the disease of retinal degenerations with loss of photoreceptors (related to
      old age or genetic) on patients' daily lives, is poorly characterize without standardized
      means of measurement (usually performed with functional vision or reading tasks).

      self-assessment by a quality of life questionnaire correlated with an assessment of emotional
      state and direct observation of patients during daily life tasks are the two ways used in a
      scientific framework to collect data on the difficulties encountered by patients in their
      daily life.

      The aim of this project is to determine the behavioral effects of retinitis pigmentosa (RP)
      by the effects of performance reductions related to adapting to darkness and visual field
      restriction. Those assessments will be in real conditions but also in virtual reality (VR).

      This tool can be used to measure a therapeutic benefit for new treatments (like gene therapy,
      retinal implants, intra vitreous injections …) for visual loss patients.
This prospective, longitudinal and non-randomized study will be conducted on 2 groups of
      people: retinitis pigmentosa's patients ( 1st and 2nd phases) and healthy volunteers patients
      (2nd phase).

      The first phase's aim (named pilot phase) is to determine the optimal parameters to achieve
      the locomotion test. Fifteen RP's eligible patients will be requiring to 4 sessions of 3
      hours to perform tests (Two sessions on real conditions and the two others on virtual
      reality).

      The second phase's aim (named validation phase) is to validate tests to assess the impact of
      peripheral visual impairment on the sensory and motor performance of patients in their daily
      life. Firstly 15 RP's patients and 15 healthy volunteers will be included in this phase
      conducted according to a plan of Simon. 21 additional patients will be including on each
      group in view of the results on the first step in this 2nd phase.

      For each patient, the duration of participation will be of 3 months for the first phase and
      14 months for the second phase. The study duration is expected to be 50 months.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: optimal Simon two-stage design
primary purpose: Other
masking: None (Open Label)
measure: Pilot calibration phase in a real environment.
time frame: Month 1
description: Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a real environment.
measure: Pilot calibration phase in a virtual environment.
time frame: Month 1
description: Defines the optimal parameters of complexity of standardized behavioral tasks thanks to a mobility test in variable light conditions carried out in a virtual environment.
measure: Validation phase on the motor performance
time frame: Month 12
description: Validation of tests to assess the impact of peripheral visual impairment on the motor performance of patients in their daily life
measure: Validation phase on the sensory performance
time frame: Month 12
description: Validation of tests to assess the impact of peripheral visual impairment on the sensory performance of patients in their daily life
measure: Validation of a locomotion test in virtual reality
time frame: Day 1 - Month 1- Month 12
description: It is to validate the construction of the test and to determine its performance in discriminating nature, its reproducibility and its sensitivity to change
measure: Quality of Life Assessment
time frame: Day1-Month 1- Month 12
description: Analyze the correlation between the results of patients' quality of life and the results of behavioral tests
measure: Measures of the evolution of the postural parameters
time frame: Day1 - Month 1 - Month 12
description: Evolution of postural's study parameters is performed by an experimental behavioral study, carried out during the same sessions as the main task of locomotion. The participants' postural stability will be correlated with the patient's visual parameters (acuity, visual field).
measure: Analyze the adverse events during the tasks' assessment
time frame: through study completion, an average of 1 year
description: Analyze the adverse events that will be collected during the performance of this study
arm group label: Retinitis Pigmentosa patients
arm group type: Experimental
description: Patients with Retinitis Pigmentosa (RP) at different stages of impairment of the visual field, acuity and sensitivity to contrasts 15 patients will be included in phase 1 versus 36 in phase 2 (15 in step 1 and 21 in step 2).
arm group label: healthy volunteers patients
arm group type: Other
description: 36 patients will be included just in phase 2 (15 in step 1 and 21 in step 2).
intervention type: Behavioral
intervention name: performance of behavioral locomotion tasks phase 1
description: The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1)
arm group label: Retinitis Pigmentosa patients
intervention type: Behavioral
intervention name: performance of behavioral locomotion tasks phase 2
description: The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)
arm group label: Retinitis Pigmentosa patients
arm group label: healthy volunteers patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Saddek MOHAND-SAID, MD
role: Principal Investigator
affiliation: Centre national d'ophtalmologique des 15-20
last name: Tania RILCY
phone: +33140021126
email: trilcy@15-20.fr
last name: Hayet SERHANE
phone: +33140021144
email: hserhane@15-20.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Retinitis
mesh term: Retinitis Pigmentosa