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/NCT05968443</url>
    </required_header>
    <id_info>
      <org_study_id>AAG-O-H-1913</org_study_id>
      <nct_id>NCT05968443</nct_id>
    </id_info>
    <brief_title>Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery</brief_title>
    <acronym>OPHTHADA</acronym>
    <official_title>Observational, Retrospective Clinical Study in Patients Undergoing Ophthalmic Surgery Using Dafilon® Suture Material (Dafilon® USP (United States Pharmacopeia) Sizes From 8/0 to 11/0)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aesculap AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>B.Braun Surgical SA</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Aesculap AG</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>
        This is an observational, retrospective postmarket clinical follow-up study and includes all&#xD;
        patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres&#xD;
        between 2018 and 2020, therefore no sample size can be given but the planned sample size&#xD;
        shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per&#xD;
        patient) to conduct meaningful subgroup analysis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 8, 2019</start_date>
    <completion_date type="Actual">May 10, 2022</completion_date>
    <primary_completion_date type="Actual">July 1, 2021</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Suture material complications</measure>
      <time_frame>up to the retrospective examination (2 to 4 years postoperatively)</time_frame>
      <description>Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Intra-operative complications</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Number of Intra-operative complications as documented in the patient's record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Post-operative complications</measure>
      <time_frame>up to the retrospective examination (2 to 4 years postoperatively)</time_frame>
      <description>Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of recurrence</measure>
      <time_frame>up to the retrospective examination (2 to 4 years postoperatively)</time_frame>
      <description>Cumulative number of recurrencies</description>
    </secondary_outcome>
    <enrollment type="Actual">200</enrollment>
    <condition>Eye Diseases</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ophthalmic surgery</intervention_name>
      <description>any ophthalmic surgery using Dafilon® suture</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients who underwent any ophthalmic surgery using Dafilon® suture in the&#xD;
          participating centre between 2018 and 2020.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient operated between 2018 - 2020 undergoing any ophthalmic surgery using Dafilon®&#xD;
               suture material (Dafilon® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at&#xD;
               the participating hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No exclusion criteria have been set&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Hamidah H Budin, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>KPJ Tawakkal KL Specialist Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>KPJ Tawakkal KL Specialist Hospital</name>
        <address>
          <city>Kuala Lumpur</city>
          <state>Wilayah Persekutuan Kuala Lumpur</state>
          <zip>53000</zip>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ophthalmologic Surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eye Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05968443
  org study id: AAG-O-H-1913
  nct id: NCT05968443
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational, retrospective postmarket clinical follow-up study and includes all
        patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres
        between 2018 and 2020, therefore no sample size can be given but the planned sample size
        shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per
        patient) to conduct meaningful subgroup analysis.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of Suture material complications
  time frame: up to the retrospective examination (2 to 4 years postoperatively)
  description: Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)
  measure: Number of Intra-operative complications
  time frame: intraoperatively
  description: Number of Intra-operative complications as documented in the patient's record
  measure: Number of Post-operative complications
  time frame: up to the retrospective examination (2 to 4 years postoperatively)
  description: Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination
  measure: Incidence of recurrence
  time frame: up to the retrospective examination (2 to 4 years postoperatively)
  description: Cumulative number of recurrencies
  intervention type: Device
  intervention name: ophthalmic surgery
  description: any ophthalmic surgery using Dafilon® suture
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Hamidah H Budin, Dr.
  role: Principal Investigator
  affiliation: KPJ Tawakkal KL Specialist Hospital
  facility: 
  country: Malaysia
  responsible party type: Sponsor
  mesh term: Eye Diseases
  sharing ipd: No