<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/NCT03797846</url>
  </required_header>
  <id_info>
    <org_study_id>1771</org_study_id>
    <nct_id>NCT03797846</nct_id>
  </id_info>
  <brief_title>Comparison of Fixation Suture Type in Glaucoma Surgery</brief_title>
  <official_title>Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Bialystok</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Bialystok</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the effectiveness and safety of two types of&#xD;
      intraoperative eye fixation: for the superior rectus muscle and traction suture in the&#xD;
      peripheral cornea.&#xD;
&#xD;
      This is a prospective randomized trial with a 6 month follow-up period, which covers patients&#xD;
      with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In&#xD;
      I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II&#xD;
      group the bridle suture for the superior rectus muscle is performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The way of the intraoperatively fixation may have some impact for postoperative results of&#xD;
      the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper&#xD;
      eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>A prospective randomized trial with a 6 month follow-up period</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP</measure>
    <time_frame>baseline and twelve months after surgery</time_frame>
    <description>the change in the level of intraocular pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BCVA</measure>
    <time_frame>baseline and twelve months after surgery</time_frame>
    <description>the change in the best corrected visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRD</measure>
    <time_frame>baseline and twelve months after surgery</time_frame>
    <description>the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Glaucoma Eye</condition>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Corneal Suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle Suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combined glaucoma surgery</intervention_name>
    <description>combined procedure with trabeculectomy and cataract removal</description>
    <arm_group_label>Corneal Suture</arm_group_label>
    <arm_group_label>Muscle Suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale&#xD;
             (Lens Opacities Classification System III)&#xD;
&#xD;
          -  primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a&#xD;
             satisfactory IOP level was not achieved despite maximum tolerable hypotensive&#xD;
             treatment, both topical and systemic&#xD;
&#xD;
          -  documented progression of loss of field of vision&#xD;
&#xD;
          -  significant daily IOP fluctuations&#xD;
&#xD;
          -  no cooperation from patient with regard to application of anti-glaucoma treatment,&#xD;
             allergy to topical medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent to participation in the study&#xD;
&#xD;
          -  prior surgical and laser procedures in the area of the eye&#xD;
&#xD;
          -  narrow- or closed-angle glaucoma&#xD;
&#xD;
          -  post-inflammatory or post-traumatic secondary glaucoma&#xD;
&#xD;
          -  chronic illness of the cornea or optic nerve&#xD;
&#xD;
          -  advanced macular degeneration&#xD;
&#xD;
          -  active inflammatory process&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  systemic steroid therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zofia Mariak, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Bialystok</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University</name>
      <address>
        <city>Białystok</city>
        <zip>15-089</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.</citation>
    <PMID>25803293</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Bialystok</investigator_affiliation>
    <investigator_full_name>Joanna Konopińska</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>ptosis</keyword>
  <keyword>combined procedures</keyword>
  <keyword>glaucoma</keyword>
  <keyword>post-surgery complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data of each participant will be available on email request for all primary and secondary outcome measures</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available on email request for six months after completing recruitment</ipd_time_frame>
    <ipd_access_criteria>e-mail request, after Data Access Agreement is sign</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03797846
org study id: 1771
nct id: NCT03797846
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare the effectiveness and safety of two types of
      intraoperative eye fixation: for the superior rectus muscle and traction suture in the
      peripheral cornea.

      This is a prospective randomized trial with a 6 month follow-up period, which covers patients
      with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In
      I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II
      group the bridle suture for the superior rectus muscle is performed.
The way of the intraoperatively fixation may have some impact for postoperative results of
      the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper
      eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective randomized trial with a 6 month follow-up period
primary purpose: Treatment
masking: None (Open Label)
measure: IOP
time frame: baseline and twelve months after surgery
description: the change in the level of intraocular pressure
measure: BCVA
time frame: baseline and twelve months after surgery
description: the change in the best corrected visual acuity
measure: MRD
time frame: baseline and twelve months after surgery
description: the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm
arm group label: Corneal Suture
arm group type: Active Comparator
description: intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery
arm group label: Muscle Suture
arm group type: Active Comparator
description: intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery
intervention type: Procedure
intervention name: combined glaucoma surgery
description: combined procedure with trabeculectomy and cataract removal
arm group label: Corneal Suture
arm group label: Muscle Suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zofia Mariak, Prof
role: Study Chair
affiliation: Medical University of Bialystok
facility: 
country: Poland
citation: Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.
PMID: 25803293
responsible party type: Principal Investigator
investigator affiliation: Medical University of Bialystok
investigator full name: Joanna Konopińska
investigator title: MD, PhD
mesh term: Glaucoma
sharing ipd: Yes
ipd description: De-identified data of each participant will be available on email request for all primary and secondary outcome measures
ipd info type: Study Protocol
ipd time frame: Data will be available on email request for six months after completing recruitment
ipd access criteria: e-mail request, after Data Access Agreement is sign