<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/NCT03807869</url>
  </required_header>
  <id_info>
    <org_study_id>1772</org_study_id>
    <nct_id>NCT03807869</nct_id>
  </id_info>
  <brief_title>Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma</brief_title>
  <official_title>Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma</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>
    <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>
      Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation&#xD;
      depended on number of antiglaucoma eye drops at baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The scientific aim of the project is to estimate the average reduction of intraocular&#xD;
      pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12&#xD;
      months observation period. The subject must suffer from glaucoma and cataract at the same&#xD;
      time, and qualify for a cataract surgery. The group will be composed of 40 patients of the&#xD;
      Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract&#xD;
      removal surgery. They will be surgically implanted an I-stent by-pass during&#xD;
      phacoemulsification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IntraOcular Pressure measurement (IOP)</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>change in the level of intraocular pressure measured with Goldmann applanation tonometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Best Corrected Visual Acuity measurement (BCVA)</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>change in best corrected visual acuity measured with Snellen charts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of antiglaucoma medicines</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>change in number of antiglaucoma medicines used before and after surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>coexisting glaucoma and cataract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combined glaucoma surgery</intervention_name>
    <description>phacoemulsification of cataract and I-stent by-pass implantation</description>
    <arm_group_label>coexisting glaucoma and cataract</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 Opacity Classification System III)&#xD;
&#xD;
          -  patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and&#xD;
             normal tension glaucoma (NTG), with topical hypotensive treatment&#xD;
&#xD;
          -  written consent to involvement and participation in the study for a period of at least&#xD;
             12 months was obtained from all patients after they had first been informed of the&#xD;
             nature of the procedure and other surgical alternatives&#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>Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.</citation>
    <PMID>29476443</PMID>
  </reference>
  <results_reference>
    <citation>Chansangpetch S, Lau K, Perez CI, Nguyen N, Porco TC, Lin SC. Efficacy of Cataract Surgery With Trabecular Microbypass Stent Implantation in Combined-Mechanism Angle Closure Glaucoma Patients. Am J Ophthalmol. 2018 Nov;195:191-198. doi: 10.1016/j.ajo.2018.08.003. Epub 2018 Aug 8.</citation>
    <PMID>30098352</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>I-stent</keyword>
  <keyword>glaucoma surgery</keyword>
  <keyword>minimally invasive glaucoma surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement</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/NCT03807869
org study id: 1772
nct id: NCT03807869
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation
      depended on number of antiglaucoma eye drops at baseline.
The scientific aim of the project is to estimate the average reduction of intraocular
      pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12
      months observation period. The subject must suffer from glaucoma and cataract at the same
      time, and qualify for a cataract surgery. The group will be composed of 40 patients of the
      Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract
      removal surgery. They will be surgically implanted an I-stent by-pass during
      phacoemulsification.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: IntraOcular Pressure measurement (IOP)
time frame: baseline, 12 months
description: change in the level of intraocular pressure measured with Goldmann applanation tonometer
measure: Best Corrected Visual Acuity measurement (BCVA)
time frame: baseline, 12 months
description: change in best corrected visual acuity measured with Snellen charts
measure: number of antiglaucoma medicines
time frame: baseline, 12 months
description: change in number of antiglaucoma medicines used before and after surgery
arm group label: coexisting glaucoma and cataract
arm group type: Experimental
description: Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery
intervention type: Procedure
intervention name: combined glaucoma surgery
description: phacoemulsification of cataract and I-stent by-pass implantation
arm group label: coexisting glaucoma and cataract
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: Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.
PMID: 29476443
citation: Chansangpetch S, Lau K, Perez CI, Nguyen N, Porco TC, Lin SC. Efficacy of Cataract Surgery With Trabecular Microbypass Stent Implantation in Combined-Mechanism Angle Closure Glaucoma Patients. Am J Ophthalmol. 2018 Nov;195:191-198. doi: 10.1016/j.ajo.2018.08.003. Epub 2018 Aug 8.
PMID: 30098352
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of study completion
ipd access criteria: Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement