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/NCT06000111</url>
    </required_header>
    <id_info>
      <org_study_id>16100</org_study_id>
      <nct_id>NCT06000111</nct_id>
    </id_info>
    <brief_title>Duration of Face Down Positioning for Full-Thickness Macular Hole Repair</brief_title>
    <official_title>Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: A Randomized Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>St. Joseph's Healthcare Hamilton</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>St. Joseph's Healthcare Hamilton</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>
        A full-thickness macular hole is when there is a small gap that opens in the center part of&#xD;
        the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical&#xD;
        repair of these holes, patients have to lie face down for a number of days and nights. The&#xD;
        exact amount of time necessary to position is however unknown. The goal of this randomized&#xD;
        feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days&#xD;
        and nights of face-down positioning following pars plana vitrectomy surgery for&#xD;
        full-thickness macular holes on key patient outcomes. This study will be a feasibility study&#xD;
        to better inform a future larger clinical trial. Additionally, this investigation will be&#xD;
        examining the rates of macular hole closure, patient visual acuity following surgery, patient&#xD;
        quality of life, patient compliance, and complication rates.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 15, 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>
      <intervention_model_description>This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The surgeon will be masked to the patient's treatment allocation until after surgery is complete. At this point, the surgeon will be made aware of the patient's treatment allocation and inform the patient in the recovery room regarding their treatment allocation. The participants and the clinical teams managing the patient care will be unmasked. The outcome assessors will be masked.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment Rate</measure>
      <time_frame>The recruitment rate will be calculated during the recruitment period.</time_frame>
      <description>This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention Rate</measure>
      <time_frame>The retention rate will be calculated at 3-months post-operatively.</time_frame>
      <description>This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Completion Rate</measure>
      <time_frame>The completion rate will be calculated at 3-months post-operatively.</time_frame>
      <description>This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment Time</measure>
      <time_frame>The recruitment time will be calculated during the recruitment period.</time_frame>
      <description>This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Macular Hole Closure Rate</measure>
      <time_frame>3-months post-operatively</time_frame>
      <description>The rate of macular hole closure will be evaluated by 2-independent readers masked to treatment allocation. They will grade the outcome as open or closed. Outcomes classified as open will be further divided into open and flat (without a cuff of subretinal fluid) or open and elevated (with a cuff of subretinal fluid).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best-Corrected Visual Acuity (BCVA)</measure>
      <time_frame>3-months post-operatively</time_frame>
      <description>Patient best-corrected visual acuity will be measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vision specific quality of life measure</measure>
      <time_frame>3-months post-operatively</time_frame>
      <description>The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be administered to patients. Possible patient scores range from 0 to 100 with a higher score representing higher vision-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance with Face Down Positioning</measure>
      <time_frame>While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.</time_frame>
      <description>Compliance will be assessed with self-administered questionnaires three times per day during the duration of positioning. The possible range of scores is from 1 to 10 with higher scores indicating better compliance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complication Rates</measure>
      <time_frame>Rates will be determined for the entire follow-up period (3-months)</time_frame>
      <description>Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Related Quality of Life Measure</measure>
      <time_frame>3-months post-operatively</time_frame>
      <description>The Quality of Life Scale (QOLS) will be administered to patients. The range of possible patient scores is from 16 to 112. Higher scores indicate higher quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Macular Holes</condition>
    <arm_group>
      <arm_group_label>Face-Down Positioning for 3-Days and Nights</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Face-Down Positioning for 7-Days and Nights</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>3 Days of face-down positioning</intervention_name>
      <description>Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.</description>
      <arm_group_label>Face-Down Positioning for 3-Days and Nights</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>7 Days of face-down positioning</intervention_name>
      <description>Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.</description>
      <arm_group_label>Face-Down Positioning for 7-Days and Nights</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Consecutive patients with an idiopathic full-thickness macular hole&#xD;
  &#xD;
            -  Symptom duration of less than 6 months&#xD;
  &#xD;
            -  Patient must agree to participate in this investigation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Macular hole minimum diameter &gt;1000 μm&#xD;
  &#xD;
            -  A history of high myopia (&gt; -6)&#xD;
  &#xD;
            -  Traumatic macular hole&#xD;
  &#xD;
            -  Amblyopia&#xD;
  &#xD;
            -  Retinal vein occlusion&#xD;
  &#xD;
            -  Inflammatory eye diseases&#xD;
  &#xD;
            -  Patients found to have a retinal tear during either the pre-operative assessment or&#xD;
               intraoperatively&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Varun Chaudhary, MD, FRCSC</last_name>
      <role>Principal Investigator</role>
      <affiliation>McMaster University, St. Joseph's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Varun Chaudhary, MD, FRCSC</last_name>
      <phone>905-573-7777</phone>
      <phone_ext>38058</phone_ext>
      <email>vchaudh@mcmaster.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Keean Nanji, MD</last_name>
      <phone>905-573-4848</phone>
      <email>Keean.Nanji@medportal.ca</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
      <investigator_full_name>Varun Chaudhary</investigator_full_name>
      <investigator_title>Professor, Department of Surgery, Chief of Ophthalmology, Hamilton Regional Eye Institute</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Retinal Perforations</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data may be shared with other researchers upon 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/NCT06000111
  org study id: 16100
  nct id: NCT06000111
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A full-thickness macular hole is when there is a small gap that opens in the center part of
        the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical
        repair of these holes, patients have to lie face down for a number of days and nights. The
        exact amount of time necessary to position is however unknown. The goal of this randomized
        feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days
        and nights of face-down positioning following pars plana vitrectomy surgery for
        full-thickness macular holes on key patient outcomes. This study will be a feasibility study
        to better inform a future larger clinical trial. Additionally, this investigation will be
        examining the rates of macular hole closure, patient visual acuity following surgery, patient
        quality of life, patient compliance, and complication rates.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The surgeon will be masked to the patient's treatment allocation until after surgery is complete. At this point, the surgeon will be made aware of the patient's treatment allocation and inform the patient in the recovery room regarding their treatment allocation. The participants and the clinical teams managing the patient care will be unmasked. The outcome assessors will be masked.
  measure: Recruitment Rate
  time frame: The recruitment rate will be calculated during the recruitment period.
  description: This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.
  measure: Retention Rate
  time frame: The retention rate will be calculated at 3-months post-operatively.
  description: This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.
  measure: Completion Rate
  time frame: The completion rate will be calculated at 3-months post-operatively.
  description: This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.
  measure: Recruitment Time
  time frame: The recruitment time will be calculated during the recruitment period.
  description: This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.
  measure: Macular Hole Closure Rate
  time frame: 3-months post-operatively
  description: The rate of macular hole closure will be evaluated by 2-independent readers masked to treatment allocation. They will grade the outcome as open or closed. Outcomes classified as open will be further divided into open and flat (without a cuff of subretinal fluid) or open and elevated (with a cuff of subretinal fluid).
  measure: Best-Corrected Visual Acuity (BCVA)
  time frame: 3-months post-operatively
  description: Patient best-corrected visual acuity will be measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
  measure: Vision specific quality of life measure
  time frame: 3-months post-operatively
  description: The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be administered to patients. Possible patient scores range from 0 to 100 with a higher score representing higher vision-related quality of life.
  measure: Compliance with Face Down Positioning
  time frame: While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.
  description: Compliance will be assessed with self-administered questionnaires three times per day during the duration of positioning. The possible range of scores is from 1 to 10 with higher scores indicating better compliance.
  measure: Complication Rates
  time frame: Rates will be determined for the entire follow-up period (3-months)
  description: Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage
  measure: Health Related Quality of Life Measure
  time frame: 3-months post-operatively
  description: The Quality of Life Scale (QOLS) will be administered to patients. The range of possible patient scores is from 16 to 112. Higher scores indicate higher quality of life.
  arm group label: Face-Down Positioning for 3-Days and Nights
  arm group type: Experimental
  description: Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.
  arm group label: Face-Down Positioning for 7-Days and Nights
  arm group type: Active Comparator
  description: Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.
  intervention type: Behavioral
  intervention name: 3 Days of face-down positioning
  description: Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
  arm group label: Face-Down Positioning for 3-Days and Nights
  intervention type: Behavioral
  intervention name: 7 Days of face-down positioning
  description: Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
  arm group label: Face-Down Positioning for 7-Days and Nights
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Varun Chaudhary, MD, FRCSC
  role: Principal Investigator
  affiliation: McMaster University, St. Joseph's Hospital
  last name: Varun Chaudhary, MD, FRCSC
  phone: 905-573-7777
  phone ext: 38058
  email: vchaudh@mcmaster.ca
  last name: Keean Nanji, MD
  phone: 905-573-4848
  email: Keean.Nanji@medportal.ca
  responsible party type: Principal Investigator
  investigator affiliation: St. Joseph's Healthcare Hamilton
  investigator full name: Varun Chaudhary
  investigator title: Professor, Department of Surgery, Chief of Ophthalmology, Hamilton Regional Eye Institute
  mesh term: Retinal Perforations
  sharing ipd: No
  ipd description: Individual participant data may be shared with other researchers upon reasonable request.