<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/NCT03836898</url>
  </required_header>
  <id_info>
    <org_study_id>PhakicIOL Presbyopia</org_study_id>
    <nct_id>NCT03836898</nct_id>
  </id_info>
  <brief_title>Presbyopic Phakic Intraocular Lens for Myopia Correction</brief_title>
  <official_title>Presbyopic Phakic Intraocular Lens for Myopia Correction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gemini Eye Clinic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gemini Eye Clinic</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 a prospective single-center study of implantations of the presbyopic version of&#xD;
      phakic intraocular lens IPCL (EyeolUK, United Kingdom).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and&#xD;
      monitored during 2 years period. Visual acuity for near and distance is evaluated, along with&#xD;
      refraction and endothelium cell density.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Change in Uncorrected Distance Visual Acuity (UDVA)</measure>
    <time_frame>2 years</time_frame>
    <description>Distance visual acuity tested without any correction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Uncorrected Near Visual Acuity (UNVA)</measure>
    <time_frame>2 years</time_frame>
    <description>Near visual acuity tested without any correction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Corrected Distance Visual Acuity (CDVA)</measure>
    <time_frame>2 years</time_frame>
    <description>Distance visual acuity tested with correction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Corrected Near Visual Acuity (CNVA)</measure>
    <time_frame>2 years</time_frame>
    <description>Near visual acuity tested with correction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in distance refraction</measure>
    <time_frame>2 years</time_frame>
    <description>Expressed as spherical equivalent sp.Eq (D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in near refraction</measure>
    <time_frame>2 years</time_frame>
    <description>Expressed as spherical equivalent sp.Eq (D)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Presbyopia</condition>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Implantation phakic intraocular lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Presbyopic posterior chamber phakic intraocular lens IPCL</intervention_name>
    <description>Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.</description>
    <arm_group_label>Implantation phakic intraocular lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CDVA &lt; 0.3 LogMAR&#xD;
&#xD;
          -  Presbyopia with moderate to high myopia&#xD;
&#xD;
          -  Phakic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal endotehleial cell density below 2000 cells/mm2&#xD;
&#xD;
          -  Corneal dystrophies&#xD;
&#xD;
          -  ACD less than 2.8 mm&#xD;
&#xD;
          -  history or current uveitis&#xD;
&#xD;
          -  acute ocular inflammation&#xD;
&#xD;
          -  glaucoma&#xD;
&#xD;
          -  chronic uveitis&#xD;
&#xD;
          -  previous intraocular or refractive surgery&#xD;
&#xD;
          -  preexisting ocular pathologic which may affect postoperative results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gemini Eye Clinic</name>
      <address>
        <city>Zlín</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03836898
org study id: PhakicIOL Presbyopia
nct id: NCT03836898
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective single-center study of implantations of the presbyopic version of
      phakic intraocular lens IPCL (EyeolUK, United Kingdom).
Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and
      monitored during 2 years period. Visual acuity for near and distance is evaluated, along with
      refraction and endothelium cell density.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Uncorrected Distance Visual Acuity (UDVA)
time frame: 2 years
description: Distance visual acuity tested without any correction
measure: Change in Uncorrected Near Visual Acuity (UNVA)
time frame: 2 years
description: Near visual acuity tested without any correction
measure: Change in Corrected Distance Visual Acuity (CDVA)
time frame: 2 years
description: Distance visual acuity tested with correction
measure: Change in Corrected Near Visual Acuity (CNVA)
time frame: 2 years
description: Near visual acuity tested with correction
measure: Change in distance refraction
time frame: 2 years
description: Expressed as spherical equivalent sp.Eq (D)
measure: Change in near refraction
time frame: 2 years
description: Expressed as spherical equivalent sp.Eq (D)
arm group label: Implantation phakic intraocular lens
arm group type: Experimental
description: Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye
intervention type: Device
intervention name: Presbyopic posterior chamber phakic intraocular lens IPCL
description: Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.
arm group label: Implantation phakic intraocular lens
criteria: 
gender: All
minimum age: 38 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Myopia
mesh term: Presbyopia
sharing ipd: Undecided