<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/NCT02236351</url>
  </required_header>
  <id_info>
    <org_study_id>H-34627</org_study_id>
    <nct_id>NCT02236351</nct_id>
  </id_info>
  <brief_title>New Pediatric Patching Method to Improve Compliance</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <brief_summary>
    <textblock>
      This project will assess whether there is a significant difference in compliance with&#xD;
      patching in amblyopic patients whose parents are instructed to pinch the superior and&#xD;
      inferior edges of the patch before applying (in order to improve comfort) versus patients&#xD;
      whose parents are instructed to place the patch evenly around the orbit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will present to the pediatric ophthalmology clinic at Texas Children's Hospital. If&#xD;
      during the course of their standard care visit it is determined by their pediatric&#xD;
      ophthalmologist or optometrist that patching is indicated and that the patient meets&#xD;
      eligibility criteria for the study, the eye doctor will explain to the patient's parents the&#xD;
      need for patching according to the standard protocol and will then mention to them the study&#xD;
      being conducted. If they are interested, an investigator will explain the study, allow&#xD;
      patients and parents to ask questions, and will then seek written informed consent. Upon&#xD;
      consent, a patient will be assigned an ID code that will be written on their signed consent&#xD;
      form. Consenting parents will then be randomized into either the control group (taught to&#xD;
      apply the patch using the standard method) or the study group ( taught to apply the patch&#xD;
      using our modified technique). The standard technique refers to applying the patch evenly and&#xD;
      flatly around the orbit, and the modified technique refers to pinching the middle of the&#xD;
      superior and inferior edges of the patch before applying so that the patch is convex and the&#xD;
      center is raised above the eye in an attempt to improve patient comfort. All patients will be&#xD;
      provided with one box of sample patches. In order to mask parents in both groups, these&#xD;
      patches will all have a small incision of 3 millimeters on the lateral edges so that parents&#xD;
      will be uncertain if they are assigned to the control or study group. An incision of this&#xD;
      size will not significantly alter the function of the patch in any way. Patients will have&#xD;
      equal odds of being assigned to either the control or study group using a random number&#xD;
      generator. Parents will not be told whether the method they are being taught is the standard&#xD;
      or modified method, and their eye doctor will not be told whether or not the parents decided&#xD;
      to enroll in the study. After using one full box of patches or after one month, whichever&#xD;
      comes first, parents will complete a questionnaire about their compliance with the prescribed&#xD;
      patching regimen and any difficulties they may have had in patching their child. We will use&#xD;
      the Amblyopia Treatment Index Patching Questionnaire designed by the Pediatric Eye Disease&#xD;
      Investigator Group, with the addition of several questions related to patients' comfort while&#xD;
      patching. Patients will be instructed to return for standard follow-up care as determined by&#xD;
      their eye doctor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survey Responses</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Amblyopia</condition>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients assigned to the Control Arm will be taught to apply their patches using the standard technique -- applying the patch evenly and flatly around the orbit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pinched Patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to the Pinched Patch Arm will be taught to apply their patches after pinching the middle of the superior and inferior edges of the patch so that the patch is convex and the center is raised above the eye.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pinch Patch/ flat Patch</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Pinched Patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients prescribed an eye patch by a pediatric ophthalmologist or optometrist to&#xD;
             treat either strabismus, anisometropia, or deprivation amblyopia&#xD;
&#xD;
          -  Patients aged from birth up to and including 7 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known skin reaction to patch or bandage adhesive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene T Tung, MD</last_name>
      <phone>832-822-3000</phone>
      <email>irene.tung@bcm.edu</email>
    </contact>
    <contact_backup>
      <last_name>Gihan Romany</last_name>
      <phone>832-822-3222</phone>
      <email>Giha.Romany@bcm.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Michael A Puente, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David K Coats, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jane C Edmond, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Evelyn A Paysse, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed A Hussein, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kimberly G Yen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Honey Herce, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amit R Bhatt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mary K Kelinske, OD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Candice Gardemal</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Miranda Freyre</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christine Romero</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kelsie B Morrison, OD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>June 19, 2023</last_update_submitted>
  <last_update_submitted_qc>June 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Irene Tintin Tung</investigator_full_name>
    <investigator_title>Assistant Professor, TCH Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>patching</keyword>
  <keyword>pediatric ophthalmology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amblyopia</mesh_term>
    <mesh_term>Strabismus</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/NCT02236351
org study id: H-34627
nct id: NCT02236351
lead sponsor: 
This project will assess whether there is a significant difference in compliance with
      patching in amblyopic patients whose parents are instructed to pinch the superior and
      inferior edges of the patch before applying (in order to improve comfort) versus patients
      whose parents are instructed to place the patch evenly around the orbit.
Patients will present to the pediatric ophthalmology clinic at Texas Children's Hospital. If
      during the course of their standard care visit it is determined by their pediatric
      ophthalmologist or optometrist that patching is indicated and that the patient meets
      eligibility criteria for the study, the eye doctor will explain to the patient's parents the
      need for patching according to the standard protocol and will then mention to them the study
      being conducted. If they are interested, an investigator will explain the study, allow
      patients and parents to ask questions, and will then seek written informed consent. Upon
      consent, a patient will be assigned an ID code that will be written on their signed consent
      form. Consenting parents will then be randomized into either the control group (taught to
      apply the patch using the standard method) or the study group ( taught to apply the patch
      using our modified technique). The standard technique refers to applying the patch evenly and
      flatly around the orbit, and the modified technique refers to pinching the middle of the
      superior and inferior edges of the patch before applying so that the patch is convex and the
      center is raised above the eye in an attempt to improve patient comfort. All patients will be
      provided with one box of sample patches. In order to mask parents in both groups, these
      patches will all have a small incision of 3 millimeters on the lateral edges so that parents
      will be uncertain if they are assigned to the control or study group. An incision of this
      size will not significantly alter the function of the patch in any way. Patients will have
      equal odds of being assigned to either the control or study group using a random number
      generator. Parents will not be told whether the method they are being taught is the standard
      or modified method, and their eye doctor will not be told whether or not the parents decided
      to enroll in the study. After using one full box of patches or after one month, whichever
      comes first, parents will complete a questionnaire about their compliance with the prescribed
      patching regimen and any difficulties they may have had in patching their child. We will use
      the Amblyopia Treatment Index Patching Questionnaire designed by the Pediatric Eye Disease
      Investigator Group, with the addition of several questions related to patients' comfort while
      patching. Patients will be instructed to return for standard follow-up care as determined by
      their eye doctor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Survey Responses
time frame: baseline
arm group label: Control
arm group type: Placebo Comparator
description: Patients assigned to the Control Arm will be taught to apply their patches using the standard technique -- applying the patch evenly and flatly around the orbit.
arm group label: Pinched Patch
arm group type: Experimental
description: Patients assigned to the Pinched Patch Arm will be taught to apply their patches after pinching the middle of the superior and inferior edges of the patch so that the patch is convex and the center is raised above the eye.
intervention type: Device
intervention name: Pinch Patch/ flat Patch
arm group label: Control
arm group label: Pinched Patch
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Irene Tintin Tung
investigator title: Assistant Professor, TCH Ophthalmology
mesh term: Amblyopia
mesh term: Strabismus