xml: <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/NCT05984758</url>
    </required_header>
    <id_info>
      <org_study_id>21PL04</org_study_id>
      <secondary_id>IRAS</secondary_id>
      <nct_id>NCT05984758</nct_id>
    </id_info>
    <brief_title>Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis</brief_title>
    <acronym>UVESCREEN1</acronym>
    <official_title>A Randomised Feasibility Study of Imaging Based Uveitis Screening for Children With Juvenile Idiopathic Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Child Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institute of Child Health</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study seeks to describe, for children undergoing uveitis surveillance following a new&#xD;
        diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a&#xD;
        randomised comparative study of routine slit lamp examination (SLE) versus imaging based&#xD;
        (anterior segment optical coherence tomography, OCT) surveillance in order to inform the&#xD;
        development of a larger multi-centre trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will compare imaging-based surveillance to routine clinical surveillance for&#xD;
        uveitis in children with juvenile idiopathic arthritis (JIA) in order to support the design&#xD;
        of a future study.&#xD;
  &#xD;
        Childhood uveitis is a rare inflammatory eye disease. Half of all children with uveitis also&#xD;
        have a joint disorder: juvenile idiopathic arthritis (or JIA). Children with JIA must travel&#xD;
        to a specialist centre every three months to have eye examinations in an attempt to pick&#xD;
        uveitis up early enough to prevent visual loss.&#xD;
  &#xD;
        Optical coherence tomography (OCT) is a non-contact non-irradiating imaging modality. The&#xD;
        investigators have recently demonstrated that novel application of OCT for uveitis detection&#xD;
        in children is feasible, acceptable to families, repeatable, sensitive, and specific. The&#xD;
        investigators have also found that families welcome the objectivity of imaging-based&#xD;
        diagnosis. Standardised operating protocols for image acquisition and analysis have been&#xD;
        developed across three imaging platforms (Optovue, Casia and Heidelberg OCT machines).&#xD;
  &#xD;
        The investigators will be undertaking a feasibility study which compares routine clinical&#xD;
        examination based uveitis surveillance to imaging based surveillance in order to provide the&#xD;
        necessary information to address this issue in a larger scale clinical trial of clinical and&#xD;
        cost-effectiveness, and explore issues around the impact of objective disease metrics on&#xD;
        family perceptions of disease and treatment, as well as the perceptions of children, families&#xD;
        and clinical staff on the use of automated diagnostic tools.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients who meet the eligibility criteria</measure>
      <time_frame>18Months</time_frame>
      <description>Feasibility data for larger scale study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of eligible patients recruited</measure>
      <time_frame>18Months</time_frame>
      <description>Feasibility data for larger scale study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients that withdraw due to loss of consent or are lost to follow-up</measure>
      <time_frame>18Months</time_frame>
      <description>Feasibility data for larger scale study</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Success</measure>
      <time_frame>12Months</time_frame>
      <description>Success rates (ie agreement with routine clinical examination, set at 100% for routine examination arm, and analysed at 6 months and 12 months milestones for OCT arm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric quality of life inventory (PedsQL) child self-report</measure>
      <time_frame>12Months</time_frame>
      <description>Health related quality of life, through child self-report, items linearly score on 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scoring (VAS) of examination procedures</measure>
      <time_frame>12Months</time_frame>
      <description>Scale running from 0 - 100, with higher score meaning better experience as reported by child</description>
    </secondary_outcome>
    <other_outcome>
      <measure>New diagnoses</measure>
      <time_frame>12months</time_frame>
      <description>Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Uveitis, Anterior</condition>
    <condition>Juvenile Idiopathic Arthritis</condition>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Routine examination for uveitis with assessment of visual function followed by slit lamp examination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ASOCT imaging</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>AS-OCT imaging</intervention_name>
      <description>Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines</description>
      <arm_group_label>ASOCT imaging</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Slit lamp examination</intervention_name>
      <description>SLE of anterior chamber</description>
      <arm_group_label>Standard care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients newly diagnosed (within preceding 12 months) with JIA who are eligible for&#xD;
               uveitis surveillance&#xD;
  &#xD;
            -  Aged 2-12 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A previous / existing diagnosis of uveitis&#xD;
  &#xD;
            -  Any co-existing ocular or neurological abnormality which impacts on current corrected&#xD;
               visual function, or could impact on future corrected visual function&#xD;
  &#xD;
            -  Developmental/learning difficulties that preclude concordance with examination /&#xD;
               informed assent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ameenat Solebo</last_name>
      <phone>+44 20 3987 2162</phone>
      <email>a.solebo@ucl.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Great Ormond Street Hospital</name>
        <address>
          <city>London</city>
          <zip>WC1n 1DH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Ameenat Lola Solebo, PhD FRCOphth</last_name>
        <phone>+44 20 3987 2162</phone>
        <email>lola.solebo@gosh.nhs.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Screening</keyword>
    <keyword>Surveillance</keyword>
    <keyword>Imaging</keyword>
    <keyword>Optical coherence tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Juvenile</mesh_term>
      <mesh_term>Uveitis</mesh_term>
      <mesh_term>Uveitis, Anterior</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD shared only after dissemination of study findings and only on reasonable request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984758
  org study id: 21PL04
  secondary id: IRAS
  nct id: NCT05984758
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study seeks to describe, for children undergoing uveitis surveillance following a new
        diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a
        randomised comparative study of routine slit lamp examination (SLE) versus imaging based
        (anterior segment optical coherence tomography, OCT) surveillance in order to inform the
        development of a larger multi-centre trial.
  This study will compare imaging-based surveillance to routine clinical surveillance for
        uveitis in children with juvenile idiopathic arthritis (JIA) in order to support the design
        of a future study.
  
        Childhood uveitis is a rare inflammatory eye disease. Half of all children with uveitis also
        have a joint disorder: juvenile idiopathic arthritis (or JIA). Children with JIA must travel
        to a specialist centre every three months to have eye examinations in an attempt to pick
        uveitis up early enough to prevent visual loss.
  
        Optical coherence tomography (OCT) is a non-contact non-irradiating imaging modality. The
        investigators have recently demonstrated that novel application of OCT for uveitis detection
        in children is feasible, acceptable to families, repeatable, sensitive, and specific. The
        investigators have also found that families welcome the objectivity of imaging-based
        diagnosis. Standardised operating protocols for image acquisition and analysis have been
        developed across three imaging platforms (Optovue, Casia and Heidelberg OCT machines).
  
        The investigators will be undertaking a feasibility study which compares routine clinical
        examination based uveitis surveillance to imaging based surveillance in order to provide the
        necessary information to address this issue in a larger scale clinical trial of clinical and
        cost-effectiveness, and explore issues around the impact of objective disease metrics on
        family perceptions of disease and treatment, as well as the perceptions of children, families
        and clinical staff on the use of automated diagnostic tools.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Proportion of patients who meet the eligibility criteria
  time frame: 18Months
  description: Feasibility data for larger scale study
  measure: Number of eligible patients recruited
  time frame: 18Months
  description: Feasibility data for larger scale study
  measure: Proportion of patients that withdraw due to loss of consent or are lost to follow-up
  time frame: 18Months
  description: Feasibility data for larger scale study
  measure: Success
  time frame: 12Months
  description: Success rates (ie agreement with routine clinical examination, set at 100% for routine examination arm, and analysed at 6 months and 12 months milestones for OCT arm)
  measure: Pediatric quality of life inventory (PedsQL) child self-report
  time frame: 12Months
  description: Health related quality of life, through child self-report, items linearly score on 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)
  measure: Visual analogue scoring (VAS) of examination procedures
  time frame: 12Months
  description: Scale running from 0 - 100, with higher score meaning better experience as reported by child
  measure: New diagnoses
  time frame: 12months
  description: Number of new diagnoses of uveitis / Number of new diagnosis of other visual/ocular problems
  arm group label: Standard care
  arm group type: Active Comparator
  description: Routine examination for uveitis with assessment of visual function followed by slit lamp examination
  arm group label: ASOCT imaging
  arm group type: Experimental
  description: Assessment of visual function followed by image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
  intervention type: Diagnostic Test
  intervention name: AS-OCT imaging
  description: Image acquisition with the Optovue RTVue OCT and the Heidelberg Spectralis OCT2 machines
  arm group label: ASOCT imaging
  intervention type: Diagnostic Test
  intervention name: Slit lamp examination
  description: SLE of anterior chamber
  arm group label: Standard care
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Ameenat Solebo
  phone: +44 20 3987 2162
  email: a.solebo@ucl.ac.uk
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Juvenile
  mesh term: Uveitis
  mesh term: Uveitis, Anterior
  sharing ipd: No
  ipd description: IPD shared only after dissemination of study findings and only on reasonable request