<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/NCT03793101</url>
  </required_header>
  <id_info>
    <org_study_id>EYE0001</org_study_id>
    <nct_id>NCT03793101</nct_id>
  </id_info>
  <brief_title>Biaxial Microincision Cataract Surgery Technique</brief_title>
  <acronym>BiMICS14vs18</acronym>
  <official_title>Analysis of Quality of Vision and Eye Tissue Complications in Patients Operated With Biaxial Microincision Surgery Technique.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eyemed Centrum Okulistyczne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eyemed Centrum Okulistyczne</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>
      To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial&#xD;
      microincision cataract surgery in elderly population, including diabetic and non-diabetic&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Modern trends in cataract surgery is the bimanual MICS technique. MICS significant&#xD;
      development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision.&#xD;
      This is not only a change in surgery technique, but it is a significant progress in safety&#xD;
      and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to&#xD;
      reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract&#xD;
      surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and&#xD;
      provides the opportunity for fast visual rehabilitation from the first week after cataract&#xD;
      surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique&#xD;
      fully meet the requirements of modern refractive intraocular surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 12, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Snellen charts, EDTRS charts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Keratometry</measure>
    <time_frame>3 months</time_frame>
    <description>Diopters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgically Induced Astigmatism, SIA</measure>
    <time_frame>3 months</time_frame>
    <description>Diopters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Higher Order Aberrations, HOAs</measure>
    <time_frame>3 months</time_frame>
    <description>Micrones</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal Incision thickness</measure>
    <time_frame>3 nmonths</time_frame>
    <description>Micrones</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Cataract Senile</condition>
  <arm_group>
    <arm_group_label>BiMICS 1.4</arm_group_label>
    <description>Group 1.4 - Patients operated with 1.4 mm BiMICS technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BiMICS 1.8</arm_group_label>
    <description>Group 1.8 - Patients operated with 1.8 mm BiMICS technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BiMICS</intervention_name>
    <description>Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.</description>
    <arm_group_label>BiMICS 1.4</arm_group_label>
    <arm_group_label>BiMICS 1.8</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Clinical diagnose of senile cataract.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Eye trauma in anamnesis.&#xD;
&#xD;
          2. Eye surgery in anamnesis.&#xD;
&#xD;
          3. Corneal surgery in anamnesis.&#xD;
&#xD;
          4. Corneal irregular astigmatism.&#xD;
&#xD;
          5. Corneal ectasia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paweł Klonowski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eyemed Centrum Okulistyczne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eyemed Centrum Okulistyczne</name>
      <address>
        <city>Lublin</city>
        <zip>20-093</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153898/</url>
    <description>MICS and Incise IOL</description>
  </link>
  <link>
    <url>https://www.karger.com/Article/Abstract/364808</url>
    <description>MICS and HOA</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eyemed Centrum Okulistyczne</investigator_affiliation>
    <investigator_full_name>Paweł Klonowski</investigator_full_name>
    <investigator_title>Dr Paweł Klonowski Medical Director</investigator_title>
  </responsible_party>
  <keyword>BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>UCVA, BCVA, SIA, HOAs, Corneal Incision thickness</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_time_frame>from August 2019 until December 2020</ipd_time_frame>
    <ipd_access_criteria>only on request</ipd_access_criteria>
    <ipd_url>http://eyemed.pl</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://eyemed.pl</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03793101
org study id: EYE0001
nct id: NCT03793101
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial
      microincision cataract surgery in elderly population, including diabetic and non-diabetic
      patients.
Modern trends in cataract surgery is the bimanual MICS technique. MICS significant
      development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision.
      This is not only a change in surgery technique, but it is a significant progress in safety
      and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to
      reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract
      surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and
      provides the opportunity for fast visual rehabilitation from the first week after cataract
      surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique
      fully meet the requirements of modern refractive intraocular surgery.
observational model: Case-Control
time perspective: Retrospective
measure: Visual acuity
time frame: 3 months
description: Snellen charts, EDTRS charts
measure: Keratometry
time frame: 3 months
description: Diopters
measure: Surgically Induced Astigmatism, SIA
time frame: 3 months
description: Diopters
measure: Higher Order Aberrations, HOAs
time frame: 3 months
description: Micrones
measure: Corneal Incision thickness
time frame: 3 nmonths
description: Micrones
arm group label: BiMICS 1.4
description: Group 1.4 - Patients operated with 1.4 mm BiMICS technique
arm group label: BiMICS 1.8
description: Group 1.8 - Patients operated with 1.8 mm BiMICS technique
intervention type: Procedure
intervention name: BiMICS
description: Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.
arm group label: BiMICS 1.4
arm group label: BiMICS 1.8
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paweł Klonowski, MD
role: Principal Investigator
affiliation: Eyemed Centrum Okulistyczne
facility: 
country: Poland
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153898/
description: MICS and Incise IOL
url: https://www.karger.com/Article/Abstract/364808
description: MICS and HOA
responsible party type: Principal Investigator
investigator affiliation: Eyemed Centrum Okulistyczne
investigator full name: Paweł Klonowski
investigator title: Dr Paweł Klonowski Medical Director
mesh term: Cataract
sharing ipd: Yes
ipd description: UCVA, BCVA, SIA, HOAs, Corneal Incision thickness
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 time frame: from August 2019 until December 2020
ipd access criteria: only on request
ipd url: http://eyemed.pl
study doc: 