<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/NCT03035292</url>
  </required_header>
  <id_info>
    <org_study_id>159569</org_study_id>
    <secondary_id>REC17/EE/0010</secondary_id>
    <nct_id>NCT03035292</nct_id>
  </id_info>
  <brief_title>Choroidal Reflectance Camera for the Detection of Congenital Cataracts</brief_title>
  <official_title>Proof of Concept Trial of a Novel Imaging System to Assess and Document Choroidal Reflectance in Infants for the Detection of Cataract and Media Opacities.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</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>
      Sensitivity and specificity of current screening methods for congenital cataracts in neonates&#xD;
      is poor. This results in delayed diagnosis and management which can decrease the visual&#xD;
      prognosis following cataract surgery. It also results in many false positives with resultant&#xD;
      unnecessary healthcare costs in specialist paediatric ophthalmology services. The&#xD;
      investigator has developed a new digital technique to improve the accuracy of screening for&#xD;
      congenital cataract and this study will compare this new test with the current test&#xD;
      performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All babies born in the United Kingdom undergo eye screening at birth and 6-8 weeks to enable&#xD;
      the early diagnosis and management of congenital cataract, a treatable but potentially&#xD;
      blinding condition affecting 1 in 2000 newborns. The current technique involves the&#xD;
      assessment of the &quot;red reflex&quot; - the orange/red glow in the pupil seen during ophthalmoscopy&#xD;
      (or flash photography) due to reflectance of light from the back of the eye. In reality,&#xD;
      testing can be technically difficult because the pupil constricts to light during the&#xD;
      examination and , particularly in babies of Asian and Afro-Caribbean ancestry, the red-reflex&#xD;
      can be dim due to the effect of ocular pigmentation. As a result less than 50% of congenital&#xD;
      cataracts are currently identified up by screening. Early visual experience is required for&#xD;
      good visual development and a delay in the surgical management of cataracts results in&#xD;
      sub-optimal visual development and visual impairment.&#xD;
&#xD;
      The neonatal congenital cataract screening tests are performed by a range of healthcare&#xD;
      professionals including nurses, midwives and doctors.&#xD;
&#xD;
      The investigators have developed a new digital camera imaging system based on a modified&#xD;
      mobile phone which improves the detection of choroidal reflectance, improving the pick up&#xD;
      rate of cataract and other congenital eye malformations and allowing documentation of the&#xD;
      examination and telemedicine of the digital image. The investigators predict that this will&#xD;
      facilitate screening and improve the early detection and management of congenital cataract&#xD;
      worldwide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2017</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>Test of diagnostic sensitivity</measure>
    <time_frame>8 months</time_frame>
    <description>Comparison of the sensitivity (true positive rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test of diagnostic specificity</measure>
    <time_frame>8 months</time_frame>
    <description>Comparison of the specificity (true negative rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of ease of use in differing ethnic groups</measure>
    <time_frame>8 months</time_frame>
    <description>Comparison of difficulty of assessment using a questionnaire completed by the examiner with reference to ethnic group</description>
  </secondary_outcome>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Congenital Cataract</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Babies undergoing screening for congenital cataracts as part of the Newborn and Infant&#xD;
        Physical examinations (NIPE). Infants and children up to 5 years of age attending a&#xD;
        specialist paediatric ophthalmology clinic with or without known cataracts.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All newborns having NIPE screening.&#xD;
&#xD;
          -  All children under 5 years of age attending paediatric ophthalmology clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents / carers with poor conversant English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louise E Allen, MBBS MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge University Hospitals NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Louise E Allen, MBBS MD</last_name>
    <phone>+441223 216700</phone>
    <email>louise.allen@addenbrookes.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Humma Shahid, MBBS FRCOPhth</last_name>
      <email>Humma.shahid@addenbrookes.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Rahi JS, Dezateux C. National cross sectional study of detection of congenital and infantile cataract in the United Kingdom: role of childhood screening and surveillance. The British Congenital Cataract Interest Group. BMJ. 1999 Feb 6;318(7180):362-5. doi: 10.1136/bmj.318.7180.362.</citation>
    <PMID>9933197</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Dr Louise Allen</investigator_full_name>
    <investigator_title>Consultant Paediatric Ophthalmologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 11, 2018</submitted>
    <returned>January 17, 2019</returned>
    <submitted>July 8, 2020</submitted>
    <returned>July 21, 2020</returned>
    <submitted>July 26, 2020</submitted>
    <returned>August 7, 2020</returned>
    <submitted>January 12, 2021</submitted>
    <returned>January 29, 2021</returned>
    <submitted>August 6, 2021</submitted>
    <submission_canceled>August 8, 2021</submission_canceled>
    <submitted>February 22, 2022</submitted>
    <returned>May 10, 2022</returned>
    <submitted>January 30, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03035292
org study id: 159569
secondary id: REC17/EE/0010
nct id: NCT03035292
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sensitivity and specificity of current screening methods for congenital cataracts in neonates
      is poor. This results in delayed diagnosis and management which can decrease the visual
      prognosis following cataract surgery. It also results in many false positives with resultant
      unnecessary healthcare costs in specialist paediatric ophthalmology services. The
      investigator has developed a new digital technique to improve the accuracy of screening for
      congenital cataract and this study will compare this new test with the current test
      performed.
All babies born in the United Kingdom undergo eye screening at birth and 6-8 weeks to enable
      the early diagnosis and management of congenital cataract, a treatable but potentially
      blinding condition affecting 1 in 2000 newborns. The current technique involves the
      assessment of the "red reflex" - the orange/red glow in the pupil seen during ophthalmoscopy
      (or flash photography) due to reflectance of light from the back of the eye. In reality,
      testing can be technically difficult because the pupil constricts to light during the
      examination and , particularly in babies of Asian and Afro-Caribbean ancestry, the red-reflex
      can be dim due to the effect of ocular pigmentation. As a result less than 50% of congenital
      cataracts are currently identified up by screening. Early visual experience is required for
      good visual development and a delay in the surgical management of cataracts results in
      sub-optimal visual development and visual impairment.

      The neonatal congenital cataract screening tests are performed by a range of healthcare
      professionals including nurses, midwives and doctors.

      The investigators have developed a new digital camera imaging system based on a modified
      mobile phone which improves the detection of choroidal reflectance, improving the pick up
      rate of cataract and other congenital eye malformations and allowing documentation of the
      examination and telemedicine of the digital image. The investigators predict that this will
      facilitate screening and improve the early detection and management of congenital cataract
      worldwide.
observational model: Cohort
time perspective: Prospective
measure: Test of diagnostic sensitivity
time frame: 8 months
description: Comparison of the sensitivity (true positive rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination
measure: Test of diagnostic specificity
time frame: 8 months
description: Comparison of the specificity (true negative rate) of diagnosis of congenital cataract using the choroidal reflectance camera compared to current method with reference to a gold standard examination
measure: Comparison of ease of use in differing ethnic groups
time frame: 8 months
description: Comparison of difficulty of assessment using a questionnaire completed by the examiner with reference to ethnic group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Louise E Allen, MBBS MD
role: Principal Investigator
affiliation: Cambridge University Hospitals NHS Trust
last name: Louise E Allen, MBBS MD
phone: +441223 216700
email: louise.allen@addenbrookes.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: Rahi JS, Dezateux C. National cross sectional study of detection of congenital and infantile cataract in the United Kingdom: role of childhood screening and surveillance. The British Congenital Cataract Interest Group. BMJ. 1999 Feb 6;318(7180):362-5. doi: 10.1136/bmj.318.7180.362.
PMID: 9933197
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Dr Louise Allen
investigator title: Consultant Paediatric Ophthalmologist
mesh term: Cataract
sharing ipd: No
submitted: July 11, 2018
returned: January 17, 2019
submitted: July 8, 2020
returned: July 21, 2020
submitted: July 26, 2020
returned: August 7, 2020
submitted: January 12, 2021
returned: January 29, 2021
submitted: August 6, 2021
submission canceled: August 8, 2021
submitted: February 22, 2022
returned: May 10, 2022
submitted: January 30, 2023