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/NCT05987878</url>
    </required_header>
    <id_info>
      <org_study_id>SMCI-22-0213</org_study_id>
      <nct_id>NCT05987878</nct_id>
    </id_info>
    <brief_title>Single Minimal Conjunctival Incision for Strabismus</brief_title>
    <official_title>Single Minimal Conjunctival Incision for Rectus Muscles</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Autonoma de Madrid</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Autonoma de Madrid</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>
        The purpose of this investigation is to study the feasibility and inflammatory response of&#xD;
        surgery for rectus muscles using a small single bulbar conjunctival incision posterior and&#xD;
        parallel to the muscle insertion.&#xD;
  &#xD;
        Patients requiring surgery of at least one rectus muscle with several diagnoses, operated&#xD;
        under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery,&#xD;
        will be recruited. Routinary clinical ophthalmological examination will be carried out. After&#xD;
        applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and&#xD;
        parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA&#xD;
        suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main&#xD;
        outcome measure will be duration of swelling and hemorrhage, and secondary outcome measure&#xD;
        will be motor outcome at 2 months after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose/Background: To study the feasibility and inflammatory response of surgery for rectus&#xD;
        muscles using a small single bulbar conjunctival incision posterior and parallel to the&#xD;
        muscle insertion.&#xD;
  &#xD;
        Methods: Patients requiring surgery of at least one rectus muscle with several diagnoses,&#xD;
        operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle&#xD;
        surgery, are included. Routinary clinical ophthalmological examination is carried out. After&#xD;
        applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and&#xD;
        parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA&#xD;
        suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main&#xD;
        outcome measure is duration of swelling and hemorrhage, and secondary outcome measure is&#xD;
        motor outcome at 2 months after surgery. Results are compared with retrospectively collected&#xD;
        data of patients operated using limbal (n= 20) and fornix incision (n= 21) as a point of&#xD;
        reference.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 31, 2021</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of conjunctival swelling/hemorrhage</measure>
      <time_frame>2 months</time_frame>
      <description>Evaluate duration of conjunctival swelling/hemorrhage</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)</measure>
      <time_frame>2 months</time_frame>
      <description>Evaluate motor status at 2 months after surgery</description>
    </secondary_outcome>
    <enrollment type="Actual">25</enrollment>
    <condition>Strabismus, Comitant</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>single minimal conjunctival incision</intervention_name>
      <description>A 5-0 PGA traction suture was used near the corneal limbus corresponding to the operated muscle. A 3-4 mm single conjunctival incision posterior and parallel to the insertion in medial, lateral or superior rectus muscle was used. A hang-back recession of the muscle was done using 6-0 PGA suture. The conjunctiva was closed by an 8-0 PGA single stitch with knot burial</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          25 subjects who required surgery of rectus muscle in comitant strabismus&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients requiring surgery of at least one rectus muscle with several diagnoses,&#xD;
               operated under general or topical / sub-Tenon's anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients had no previous eye muscle surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jaime Tejedor, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UAM</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>UAM</name>
        <address>
          <city>Madrid</city>
          <zip>28029</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Autonoma de Madrid</investigator_affiliation>
      <investigator_full_name>Jaime Tejedor</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Strabismus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Data shared when solicited to the PI</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/NCT05987878
  org study id: SMCI-22-0213
  nct id: NCT05987878
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this investigation is to study the feasibility and inflammatory response of
        surgery for rectus muscles using a small single bulbar conjunctival incision posterior and
        parallel to the muscle insertion.
  
        Patients requiring surgery of at least one rectus muscle with several diagnoses, operated
        under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery,
        will be recruited. Routinary clinical ophthalmological examination will be carried out. After
        applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and
        parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA
        suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main
        outcome measure will be duration of swelling and hemorrhage, and secondary outcome measure
        will be motor outcome at 2 months after surgery.
  Purpose/Background: To study the feasibility and inflammatory response of surgery for rectus
        muscles using a small single bulbar conjunctival incision posterior and parallel to the
        muscle insertion.
  
        Methods: Patients requiring surgery of at least one rectus muscle with several diagnoses,
        operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle
        surgery, are included. Routinary clinical ophthalmological examination is carried out. After
        applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and
        parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA
        suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main
        outcome measure is duration of swelling and hemorrhage, and secondary outcome measure is
        motor outcome at 2 months after surgery. Results are compared with retrospectively collected
        data of patients operated using limbal (n= 20) and fornix incision (n= 21) as a point of
        reference.
  observational model: Other
  time perspective: Prospective
  measure: Duration of conjunctival swelling/hemorrhage
  time frame: 2 months
  description: Evaluate duration of conjunctival swelling/hemorrhage
  measure: Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)
  time frame: 2 months
  description: Evaluate motor status at 2 months after surgery
  intervention type: Procedure
  intervention name: single minimal conjunctival incision
  description: A 5-0 PGA traction suture was used near the corneal limbus corresponding to the operated muscle. A 3-4 mm single conjunctival incision posterior and parallel to the insertion in medial, lateral or superior rectus muscle was used. A hang-back recession of the muscle was done using 6-0 PGA suture. The conjunctiva was closed by an 8-0 PGA single stitch with knot burial
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 60 Years
  last name: Jaime Tejedor, MD, PhD
  role: Principal Investigator
  affiliation: UAM
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Autonoma de Madrid
  investigator full name: Jaime Tejedor
  investigator title: Principal Investigator
  mesh term: Strabismus
  sharing ipd: Undecided
  ipd description: Data shared when solicited to the PI