<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/NCT02975895</url>
  </required_header>
  <id_info>
    <org_study_id>031-16</org_study_id>
    <nct_id>NCT02975895</nct_id>
  </id_info>
  <brief_title>Outcome of Different IOLs in Patients With and Without Uveitis</brief_title>
  <official_title>Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual&#xD;
      acuity. In most cases it can be managed with surgery, removing the own lens and replacing it&#xD;
      with an artificial lens, intraocular lens (IOL). These lenses are made in different materials&#xD;
      with different properties.&#xD;
&#xD;
      Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this&#xD;
      disease have an increased risk of developing cataract due to the inflammation itself and&#xD;
      treatment with steroids. They also have an increased risk of complications during surgery and&#xD;
      postoperatively. In this group the selection of IOL might be of greater importance.&#xD;
&#xD;
      The aim of this prospective randomized controlled study is to compare the outcome of&#xD;
      hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2016</start_date>
  <completion_date type="Actual">March 17, 2022</completion_date>
  <primary_completion_date type="Actual">February 22, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in inflammatory response</measure>
    <time_frame>Preoperatively and at seven occasions within two years postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of posterior capsule opacification after six months</measure>
    <time_frame>Six months (plus or minus 30 days) postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of posterior capsule opacification after one year</measure>
    <time_frame>One year (plus or minus 30 days) postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of posterior capsule opacification after two years</measure>
    <time_frame>Two years (plus or minus 2 months) postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in best corrected visual acuity assessed in decimal using Snellen charts</measure>
    <time_frame>Preoperatively and at six occasions within two years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Preoperatively and at seven occasions within two years postoperatively</time_frame>
    <description>Postoperative glaucoma or cystoid macular edema</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Uveitis</condition>
  <condition>Cataract</condition>
  <condition>Inflammation</condition>
  <condition>Posterior Capsule Opacification</condition>
  <arm_group>
    <arm_group_label>Hydrophobic IOL: Vivinex (HOYA)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intraocular lens with hydrophobic properties: Vivinex (HOYA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrophilic IOL: INCISE (Bausch+Lomb)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydrophobic IOL: Vivinex (HOYA)</intervention_name>
    <description>Patients requiring cataract surgery will be randomized to one of the two types of IOLs.</description>
    <arm_group_label>Hydrophobic IOL: Vivinex (HOYA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydrophilic IOL: INCISE (Bausch+Lomb)</intervention_name>
    <description>Patients requiring cataract surgery will be randomized to one of the two types of IOLs.</description>
    <arm_group_label>Hydrophilic IOL: INCISE (Bausch+Lomb)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cataract requiring surgery&#xD;
&#xD;
          -  Ability to understand and sign consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extensive corneal scarring&#xD;
&#xD;
          -  Other eye surgery less than 3 months before inclusion&#xD;
&#xD;
          -  Unregulated glaucoma&#xD;
&#xD;
          -  Active uveitis (increased inflammation and treatment less than 3 months before&#xD;
             inclusion)&#xD;
&#xD;
          -  Intraoperative complications (capsular tear or vitreous loss)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madeleine Zetterberg, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology</name>
      <address>
        <city>Mölndal</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</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>Cataract</mesh_term>
    <mesh_term>Uveitis</mesh_term>
    <mesh_term>Capsule Opacification</mesh_term>
    <mesh_term>Inflammation</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/NCT02975895
org study id: 031-16
nct id: NCT02975895
lead sponsor: 
has dmc: No
Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual
      acuity. In most cases it can be managed with surgery, removing the own lens and replacing it
      with an artificial lens, intraocular lens (IOL). These lenses are made in different materials
      with different properties.

      Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this
      disease have an increased risk of developing cataract due to the inflammation itself and
      treatment with steroids. They also have an increased risk of complications during surgery and
      postoperatively. In this group the selection of IOL might be of greater importance.

      The aim of this prospective randomized controlled study is to compare the outcome of
      hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in inflammatory response
time frame: Preoperatively and at seven occasions within two years postoperatively
measure: Evaluation of posterior capsule opacification after six months
time frame: Six months (plus or minus 30 days) postoperatively
measure: Evaluation of posterior capsule opacification after one year
time frame: One year (plus or minus 30 days) postoperatively
measure: Evaluation of posterior capsule opacification after two years
time frame: Two years (plus or minus 2 months) postoperatively
measure: Change in best corrected visual acuity assessed in decimal using Snellen charts
time frame: Preoperatively and at six occasions within two years postoperatively
measure: Complications
time frame: Preoperatively and at seven occasions within two years postoperatively
description: Postoperative glaucoma or cystoid macular edema
arm group label: Hydrophobic IOL: Vivinex (HOYA)
arm group type: Other
description: Intraocular lens with hydrophobic properties: Vivinex (HOYA).
arm group label: Hydrophilic IOL: INCISE (Bausch+Lomb)
arm group type: Other
description: Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).
intervention type: Device
intervention name: Hydrophobic IOL: Vivinex (HOYA)
description: Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
arm group label: Hydrophobic IOL: Vivinex (HOYA)
intervention type: Device
intervention name: Hydrophilic IOL: INCISE (Bausch+Lomb)
description: Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
arm group label: Hydrophilic IOL: INCISE (Bausch+Lomb)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Madeleine Zetterberg, MD, PhD
role: Principal Investigator
affiliation: Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Cataract
mesh term: Uveitis
mesh term: Capsule Opacification
mesh term: Inflammation
sharing ipd: Undecided