<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/NCT03276104</url>
  </required_header>
  <id_info>
    <org_study_id>2017/5506</org_study_id>
    <nct_id>NCT03276104</nct_id>
  </id_info>
  <brief_title>Late In-the-bag intraOcular Lens dislocatioN Surgery</brief_title>
  <acronym>LION</acronym>
  <official_title>Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South-Eastern Norway Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</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>
      Overall aim of the study is to compare the safety and efficacy of two different surgical&#xD;
      methods to treat Late In-the-bag intraocular lens dislocation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery&#xD;
      where the blurred biological lens is replaced with an artificial clear lens (IOL). Most&#xD;
      people who operate achieve full vision. Nevertheless, serious complications may occasionally&#xD;
      occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This&#xD;
      requires surgical treatment.&#xD;
&#xD;
      In this study the investigators want to compare two different surgical methods used in late&#xD;
      dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly&#xD;
      affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an&#xD;
      IOL fixed to the iris.&#xD;
&#xD;
      The focus of the trial will be especially on complications and other eye changes in the early&#xD;
      stages of surgery. Today, little data is available on these topics, and the investigators&#xD;
      believe that new knowledge can bring us closer to a response to preferred operating&#xD;
      techniques and an optimal drug drop regime for the patient group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 9, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammation in the anterior chamber after surgery</measure>
    <time_frame>The first weeks after surgery</time_frame>
    <description>Measured with a Laser Flare Meter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in macular thickness and occurrence of Cystoid macular edema</measure>
    <time_frame>The first months after surgery, and long term changes months up to two years after surgery</time_frame>
    <description>Evaluated with Optical Coherence Tomography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraocular pressure changes</measure>
    <time_frame>Early changes in the first weeks after surgery, and long term changes months up to two years after surgery</time_frame>
    <description>Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual acuity (BCVA)</measure>
    <time_frame>Short term (the first weeks and up to 6 months) and long term (up to two years)</time_frame>
    <description>Measured in LogMar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual acuity (BCVA)</measure>
    <time_frame>Short term (the first weeks and up to 6 months) and long term (up to two years)</time_frame>
    <description>Measured in Snellen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glare</measure>
    <time_frame>Medium term (6 months)</time_frame>
    <description>Measured by straylight meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glare</measure>
    <time_frame>Medium term (6 months)</time_frame>
    <description>Measured by subjective presence of glare</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial cells</measure>
    <time_frame>Short term (2 weeks) and long term (6months and 2 years)</time_frame>
    <description>Measured by Non-contact corneal confocal microscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra- and postoperative complications</measure>
    <time_frame>Short term and long term (first post operative day, the first weeks and months, and up to two years)</time_frame>
    <description>All relevant complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOL tilt</measure>
    <time_frame>6 months and 2 years</time_frame>
    <description>Measured with anterior segment Ultra Sound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOL tilt</measure>
    <time_frame>6 months and 2 years</time_frame>
    <description>Measured with Anterior segment optical coherence tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Refractive outcomes - subjective refraction measured with a phoropter</measure>
    <time_frame>Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years</time_frame>
    <description>To compare the refractive outcomes (short and long-term)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Refractive outcomes - subjective refraction measured with a phoropter</measure>
    <time_frame>Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years</time_frame>
    <description>To determine whether suture placement for IOL repositioning affects the refractive outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Astigmatism</measure>
    <time_frame>Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years</time_frame>
    <description>To compare astigmatism measured by keratometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Astigmatism</measure>
    <time_frame>Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years</time_frame>
    <description>To compare astigmatism measured by subjective refraction measured with phoropter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Intraocular Lens Dislocation</condition>
  <arm_group>
    <arm_group_label>IOL repositioning group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IOL exchange group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IOL repositioning</intervention_name>
    <description>Intraocular lens repositioning by scleral suturing</description>
    <arm_group_label>IOL repositioning group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IOL exchange</intervention_name>
    <description>Intraocular lens exchange with retropupillary iris-claw lens</description>
    <arm_group_label>IOL exchange group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IOL inside the capsule (&quot;in-the-bag&quot;)&#xD;
&#xD;
          -  Late dislocation (more than 6 months after cataract surgery)&#xD;
&#xD;
          -  IOL visible in the pupillary area in the supine position and hence possible to perform&#xD;
             surgery with an anterior approach&#xD;
&#xD;
          -  Eligibility for both operation methods&#xD;
&#xD;
          -  Ability to cooperate fairly well during the examinations&#xD;
&#xD;
          -  Willing to participate in the study, e.g. willingness to participate at all control&#xD;
             visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs&#xD;
             without holes in the peripheral part&#xD;
&#xD;
          -  Eyes with especially thin sclera&#xD;
&#xD;
          -  Active uveitis or pronounced iris pathology&#xD;
&#xD;
          -  Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty&#xD;
             (DSAEK)&#xD;
&#xD;
          -  Totally dislocated IOL into the posterior segment of the eye requiring pars plana&#xD;
             vitrectomy&#xD;
&#xD;
          -  Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a&#xD;
             Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)&#xD;
&#xD;
          -  Cases requiring a change in refraction. Risk of severe anisometropia&#xD;
&#xD;
          -  Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe&#xD;
             chronic obstructive pulmonary disease and severe heart failure&#xD;
&#xD;
          -  Patients using anticoagulants that cannot be discontinued&#xD;
&#xD;
        For patients with dislocated IOLs in both eyes during the study period, only the first&#xD;
        operated eye will be included. Patients without prospects of improvement in vision will be&#xD;
        excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liv Drolsum, Prof. M.D. PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marius Dalby, M.D. PhD Cand.</last_name>
    <phone>+47 92408957</phone>
    <email>marius.dalby@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olav Kristianslund, M.D. M.Phil. PhD cand.</last_name>
      <phone>+47 41625514</phone>
      <email>olav.kristianslund@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Marius Dalby</investigator_full_name>
    <investigator_title>Principal Investigator, M.D., PhD Candidate</investigator_title>
  </responsible_party>
  <keyword>IOL dislocation</keyword>
  <keyword>Cataract</keyword>
  <keyword>Cataract surgery</keyword>
  <keyword>Scleral suturing</keyword>
  <keyword>Verisyse</keyword>
  <keyword>Iris-claw</keyword>
  <keyword>Late in-the-bag IOL dislocation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Lens Subluxation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03276104
org study id: 2017/5506
nct id: NCT03276104
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Overall aim of the study is to compare the safety and efficacy of two different surgical
      methods to treat Late In-the-bag intraocular lens dislocation.
Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery
      where the blurred biological lens is replaced with an artificial clear lens (IOL). Most
      people who operate achieve full vision. Nevertheless, serious complications may occasionally
      occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This
      requires surgical treatment.

      In this study the investigators want to compare two different surgical methods used in late
      dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly
      affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an
      IOL fixed to the iris.

      The focus of the trial will be especially on complications and other eye changes in the early
      stages of surgery. Today, little data is available on these topics, and the investigators
      believe that new knowledge can bring us closer to a response to preferred operating
      techniques and an optimal drug drop regime for the patient group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.
measure: Inflammation in the anterior chamber after surgery
time frame: The first weeks after surgery
description: Measured with a Laser Flare Meter
measure: Changes in macular thickness and occurrence of Cystoid macular edema
time frame: The first months after surgery, and long term changes months up to two years after surgery
description: Evaluated with Optical Coherence Tomography
measure: Intraocular pressure changes
time frame: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
description: Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg
measure: Best Corrected Visual acuity (BCVA)
time frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
description: Measured in LogMar
measure: Best Corrected Visual acuity (BCVA)
time frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
description: Measured in Snellen
measure: Glare
time frame: Medium term (6 months)
description: Measured by straylight meter
measure: Glare
time frame: Medium term (6 months)
description: Measured by subjective presence of glare
measure: Endothelial cells
time frame: Short term (2 weeks) and long term (6months and 2 years)
description: Measured by Non-contact corneal confocal microscopy
measure: Intra- and postoperative complications
time frame: Short term and long term (first post operative day, the first weeks and months, and up to two years)
description: All relevant complications
measure: IOL tilt
time frame: 6 months and 2 years
description: Measured with anterior segment Ultra Sound
measure: IOL tilt
time frame: 6 months and 2 years
description: Measured with Anterior segment optical coherence tomography
measure: Refractive outcomes - subjective refraction measured with a phoropter
time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
description: To compare the refractive outcomes (short and long-term)
measure: Refractive outcomes - subjective refraction measured with a phoropter
time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
description: To determine whether suture placement for IOL repositioning affects the refractive outcome
measure: Astigmatism
time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
description: To compare astigmatism measured by keratometry
measure: Astigmatism
time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
description: To compare astigmatism measured by subjective refraction measured with phoropter
arm group label: IOL repositioning group
arm group type: Active Comparator
arm group label: IOL exchange group
arm group type: Active Comparator
intervention type: Procedure
intervention name: IOL repositioning
description: Intraocular lens repositioning by scleral suturing
arm group label: IOL repositioning group
intervention type: Procedure
intervention name: IOL exchange
description: Intraocular lens exchange with retropupillary iris-claw lens
arm group label: IOL exchange group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Liv Drolsum, Prof. M.D. PhD
role: Study Chair
affiliation: Oslo University Hospital
last name: Marius Dalby, M.D. PhD Cand.
phone: +47 92408957
email: marius.dalby@gmail.com
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Marius Dalby
investigator title: Principal Investigator, M.D., PhD Candidate
mesh term: Joint Dislocations
mesh term: Lens Subluxation
sharing ipd: No