<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/NCT02257307</url>
  </required_header>
  <id_info>
    <org_study_id>14-010824</org_study_id>
    <secondary_id>U10EY017014</secondary_id>
    <nct_id>NCT02257307</nct_id>
  </id_info>
  <brief_title>Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project</brief_title>
  <official_title>Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Ancillary Study - Implementation Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Eye Institute (NEI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a&#xD;
      multi-center observational study will focus on feasibility, and relative cost-effectiveness&#xD;
      of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of&#xD;
      at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical&#xD;
      Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at&#xD;
      high risk for ROP during their stay in the neonatal intensive care unit (NICU).&#xD;
&#xD;
        -  The number of sites - 5 centers in the US&#xD;
&#xD;
        -  The number and description of participants: 500 babies with birth weights of &lt;1251g&#xD;
&#xD;
      Study Interventions and Measures:&#xD;
&#xD;
      Data from RetCam digital images obtained as part of clinical care during the routine&#xD;
      diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central&#xD;
      reading center. These de-identified images will be graded by Certified Image Readers. Results&#xD;
      of image gradings will be sent back via secure web-based platform to the Clinical Center. The&#xD;
      primary outcome measure is the turnaround time from uploading the images to feedback to the&#xD;
      Clinical Center. The secondary outcome measure is the time required to obtain retinal images&#xD;
      for babies scheduled for ROP examination in the NICU (relative cost-effectiveness).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    expired study&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 16, 2016</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Determine whether imaging evaluation can be achieved for each baby within 24 hours following uploading of images in order to provide timely feedback to the examining ophthalmologist.</measure>
    <time_frame>6 months</time_frame>
    <description>Interval from uploading the images to the secure server to the time a grading report is submitted to the Clinical Center</description>
  </primary_outcome>
  <enrollment type="Actual">244</enrollment>
  <condition>Retinopathy of Prematurity</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RetCam retinal imaging used for routine care</intervention_name>
    <description>De-identified digital images of both eyes, obtained by a non-physician Certified ROP Imager (CRI) using the RetCam Shuttle, will be uploaded to the secure server for remote evaluation by a Trained Reader. The results of the Reader's evaluation will be reported to the Clinical Center.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Premature babies (N=500) with birth weights of &lt;1251g who meet current ROP screening&#xD;
        guidelines in 5 NICUs in US.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Babies with birth weights of &lt;1251g&#xD;
&#xD;
          2. Babies having clinical examinations to screen for ROP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Referral from an outside hospital for treatment of serious ROP that is performed&#xD;
             before imaging can be obtained.&#xD;
&#xD;
          -  Congenital Non-ocular Anomalies: Babies will be excluded from this study if they have&#xD;
             a severe congenital non-ocular anomaly. Such exclusions include anencephaly, trisomy&#xD;
             13, trisomy 18, or severe cardiac or pulmonary abnormalities. The neonatologist caring&#xD;
             for the baby will determine whether a particular congenital abnormality would exclude&#xD;
             the baby from participation in this study.&#xD;
&#xD;
          -  Ocular Abnormalities: Babies will be excluded from this study if they have major&#xD;
             congenital abnormalities in one or both eyes including microphthalmos, anophthalmos,&#xD;
             anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma,&#xD;
             chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. Eyelid&#xD;
             abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely&#xD;
             affect vision, would also exclude a baby from participation. Minor abnormalities that&#xD;
             would not be expected to affect vision may not be exclusion criteria including&#xD;
             Mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>32 Weeks</minimum_age>
    <maximum_age>40 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham E Quinn, MD, MSCE</last_name>
    <role>Study Chair</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ROP</keyword>
  <keyword>retinopathy</keyword>
  <keyword>Referral warranted retinopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Retinopathy of Prematurity</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/NCT02257307
org study id: 14-010824
secondary id: U10EY017014
nct id: NCT02257307
lead sponsor: 
collaborator: 
has dmc: Yes
Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a
      multi-center observational study will focus on feasibility, and relative cost-effectiveness
      of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of
      at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical
      Center.
Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at
      high risk for ROP during their stay in the neonatal intensive care unit (NICU).

        -  The number of sites - 5 centers in the US

        -  The number and description of participants: 500 babies with birth weights of <1251g

      Study Interventions and Measures:

      Data from RetCam digital images obtained as part of clinical care during the routine
      diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central
      reading center. These de-identified images will be graded by Certified Image Readers. Results
      of image gradings will be sent back via secure web-based platform to the Clinical Center. The
      primary outcome measure is the turnaround time from uploading the images to feedback to the
      Clinical Center. The secondary outcome measure is the time required to obtain retinal images
      for babies scheduled for ROP examination in the NICU (relative cost-effectiveness).
observational model: Cohort
time perspective: Prospective
measure: Determine whether imaging evaluation can be achieved for each baby within 24 hours following uploading of images in order to provide timely feedback to the examining ophthalmologist.
time frame: 6 months
description: Interval from uploading the images to the secure server to the time a grading report is submitted to the Clinical Center
intervention type: Procedure
intervention name: RetCam retinal imaging used for routine care
description: De-identified digital images of both eyes, obtained by a non-physician Certified ROP Imager (CRI) using the RetCam Shuttle, will be uploaded to the secure server for remote evaluation by a Trained Reader. The results of the Reader's evaluation will be reported to the Clinical Center.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 32 Weeks
maximum age: 40 Weeks
healthy volunteers: No
last name: Graham E Quinn, MD, MSCE
role: Study Chair
affiliation: Children's Hospital of Philadelphia
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Retinopathy of Prematurity