<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/NCT04420962</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00174923</org_study_id>
    <secondary_id>R01EY031033</secondary_id>
    <nct_id>NCT04420962</nct_id>
  </id_info>
  <brief_title>Automated Quantitative Ulcer Analysis Study</brief_title>
  <acronym>AQUA</acronym>
  <official_title>Quantifying Microbial Keratitis to Predict Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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>
      This is a multiple site observational study that will review patient features (clinical and&#xD;
      morphologic) over a 90 day period during care of participants with microbial keratitis with&#xD;
      presence of clinically significant ≥2mm stromal infiltrate compared with participants with&#xD;
      other forms of keratitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine associations between participant features&#xD;
      (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on&#xD;
      slit lamp photography and supplemented by other imaging markers will be collected for review.&#xD;
      A medical record review at one year following participants initial visit will record any&#xD;
      corneal procedure and visual acuity testing that occurred during this window. Participants&#xD;
      will complete demographic, clinical, and standardized health surveys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Visual Acuity</measure>
    <time_frame>90 day follow up</time_frame>
    <description>Visual Acuity</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Keratitis</condition>
  <arm_group>
    <arm_group_label>Microbial Keratitis</arm_group_label>
    <description>Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Viral or Inflammatory Keratitis</arm_group_label>
    <description>Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visual Acuity</intervention_name>
    <description>Best corrected visual acuity utilizing the Snellen method</description>
    <arm_group_label>Microbial Keratitis</arm_group_label>
    <arm_group_label>Viral or Inflammatory Keratitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subject population will be those that seek care at an ophthalmology clinic for&#xD;
        microbial, non-infectious, viral, Acanthamoeba, or other keratitis and agree to participate&#xD;
        in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases- microbial keratitis (bacterial or fungal) with presence of clinically&#xD;
             significant ≥2mm stromal infiltrate&#xD;
&#xD;
          -  Controls- Inflammatory, viral, Acanthamoeba, or other keratitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prior incisional corneal surgery&#xD;
&#xD;
          -  No light perception vision&#xD;
&#xD;
          -  Corneal perforation or impending perforation&#xD;
&#xD;
          -  Inpatient status&#xD;
&#xD;
          -  Institutional status&#xD;
&#xD;
          -  Cognitively impaired&#xD;
&#xD;
          -  Prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria A Woodward, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suzanne Winter, MS</last_name>
    <phone>734-232-8185</phone>
    <email>wsuzanne@med.umich.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria A Woodward, MD, MS</last_name>
    <phone>734-763-6967</phone>
    <email>mariawood@med.umich.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Michigan- Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzanne Winter, MS</last_name>
      <phone>734-232-8185</phone>
      <email>wsuzanne@med.umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Maria A Woodward, MD, MS</last_name>
      <phone>734-763-6967</phone>
      <email>mariawoo@med.umich.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Maria A Woodward, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aravind Eye Care System</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>N. Venkatesh Prajna, DO</last_name>
      <email>prajna@aravind.org</email>
    </contact>
    <investigator>
      <last_name>N. Venkatesh Prajna, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Patel TP, Prajna NV, Farsiu S, Valikodath NG, Niziol LM, Dudeja L, Kim KH, Woodward MA. Novel Image-Based Analysis for Reduction of Clinician-Dependent Variability in Measurement of the Corneal Ulcer Size. Cornea. 2018 Mar;37(3):331-339. doi: 10.1097/ICO.0000000000001488.</citation>
    <PMID>29256985</PMID>
  </reference>
  <reference>
    <citation>Maganti N, Tan H, Niziol LM, Amin S, Hou A, Singh K, Ballouz D, Woodward MA. Natural Language Processing to Quantify Microbial Keratitis Measurements. Ophthalmology. 2019 Dec;126(12):1722-1724. doi: 10.1016/j.ophtha.2019.06.003. Epub 2019 Jun 11.</citation>
    <PMID>31307829</PMID>
  </reference>
  <reference>
    <citation>Kriegel MF, Huang J, Ashfaq HA, Niziol LM, Preethi M, Tan H, Tuohy MM, Patel TP, Prajna V, Woodward MA. Algorithm Variability in Quantification of Epithelial Defect Size in Microbial Keratitis Images. Cornea. 2020 May;39(5):628-633. doi: 10.1097/ICO.0000000000002258.</citation>
    <PMID>31977729</PMID>
  </reference>
  <reference>
    <citation>Loo J, Kriegel MF, Tuohy MM, Kim KH, Prajna V, Woodward MA, Farsiu S. Open-Source Automatic Segmentation of Ocular Structures and Biomarkers of Microbial Keratitis on Slit-Lamp Photography Images Using Deep Learning. IEEE J Biomed Health Inform. 2021 Jan;25(1):88-99. doi: 10.1109/JBHI.2020.2983549. Epub 2021 Jan 5.</citation>
    <PMID>32248131</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Maria Woodward</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Corneal Ulcer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratitis</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/NCT04420962
org study id: HUM00174923
secondary id: R01EY031033
nct id: NCT04420962
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multiple site observational study that will review patient features (clinical and
      morphologic) over a 90 day period during care of participants with microbial keratitis with
      presence of clinically significant ≥2mm stromal infiltrate compared with participants with
      other forms of keratitis.
The primary objective of this study is to determine associations between participant features
      (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on
      slit lamp photography and supplemented by other imaging markers will be collected for review.
      A medical record review at one year following participants initial visit will record any
      corneal procedure and visual acuity testing that occurred during this window. Participants
      will complete demographic, clinical, and standardized health surveys.
observational model: Case-Control
time perspective: Prospective
measure: Visual Acuity
time frame: 90 day follow up
description: Visual Acuity
arm group label: Microbial Keratitis
description: Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate
arm group label: Viral or Inflammatory Keratitis
description: Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis
intervention type: Diagnostic Test
intervention name: Visual Acuity
description: Best corrected visual acuity utilizing the Snellen method
arm group label: Microbial Keratitis
arm group label: Viral or Inflammatory Keratitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 99 Years
healthy volunteers: No
last name: Maria A Woodward, MD, MS
role: Principal Investigator
affiliation: University of Michigan
last name: Suzanne Winter, MS
phone: 734-232-8185
email: wsuzanne@med.umich.edu
last name: Maria A Woodward, MD, MS
phone: 734-763-6967
email: mariawood@med.umich.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: India
country: United States
citation: Patel TP, Prajna NV, Farsiu S, Valikodath NG, Niziol LM, Dudeja L, Kim KH, Woodward MA. Novel Image-Based Analysis for Reduction of Clinician-Dependent Variability in Measurement of the Corneal Ulcer Size. Cornea. 2018 Mar;37(3):331-339. doi: 10.1097/ICO.0000000000001488.
PMID: 29256985
citation: Maganti N, Tan H, Niziol LM, Amin S, Hou A, Singh K, Ballouz D, Woodward MA. Natural Language Processing to Quantify Microbial Keratitis Measurements. Ophthalmology. 2019 Dec;126(12):1722-1724. doi: 10.1016/j.ophtha.2019.06.003. Epub 2019 Jun 11.
PMID: 31307829
citation: Kriegel MF, Huang J, Ashfaq HA, Niziol LM, Preethi M, Tan H, Tuohy MM, Patel TP, Prajna V, Woodward MA. Algorithm Variability in Quantification of Epithelial Defect Size in Microbial Keratitis Images. Cornea. 2020 May;39(5):628-633. doi: 10.1097/ICO.0000000000002258.
PMID: 31977729
citation: Loo J, Kriegel MF, Tuohy MM, Kim KH, Prajna V, Woodward MA, Farsiu S. Open-Source Automatic Segmentation of Ocular Structures and Biomarkers of Microbial Keratitis on Slit-Lamp Photography Images Using Deep Learning. IEEE J Biomed Health Inform. 2021 Jan;25(1):88-99. doi: 10.1109/JBHI.2020.2983549. Epub 2021 Jan 5.
PMID: 32248131
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Maria Woodward
investigator title: Assistant Professor
mesh term: Keratitis
sharing ipd: No