<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/NCT03790592</url>
  </required_header>
  <id_info>
    <org_study_id>LISA tri 839MP BER-401-18</org_study_id>
    <nct_id>NCT03790592</nct_id>
  </id_info>
  <brief_title>Visual Outcomes After Presbyopic Lens Exchange</brief_title>
  <acronym>RELAX</acronym>
  <official_title>Visual Outcomes and Patient Satisfaction After Presbyopic Lens Exchange With a Trifocal Intraocular Lens (IOL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carl Zeiss Meditec AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carl Zeiss Meditec AG</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>
      Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA)&#xD;
      after Refractive Lens Exchange in presbyopic patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare preoperative and postoperative Corrected distance visual acuity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2019</start_date>
  <completion_date type="Actual">December 9, 2019</completion_date>
  <primary_completion_date type="Actual">December 9, 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>Corrected distance visual acuity</measure>
    <time_frame>4 to 6 months postop</time_frame>
    <description>preoperative and postoperative Corrected distance visual acuity will be assessed</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>trifocal IOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients implanted with a trifocal intraocular lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>trifocal IOL</intervention_name>
    <description>intraocular lens</description>
    <arm_group_label>trifocal IOL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient informed of the consequences and constraints of the protocol and who has given&#xD;
             his/her written informed consent&#xD;
&#xD;
          2. Patients of any gender, aged 18 years or older&#xD;
&#xD;
          3. Assured follow-up examinations&#xD;
&#xD;
          4. Post-operative astigmatism ≤ 0.75 Diopter&#xD;
&#xD;
          5. IOL implanted into the capsular bag with trifocal IOL in both eyes&#xD;
&#xD;
          6. Patients who had bilateral uncomplicated presbyopic lens exchange surgery in both&#xD;
             healthy eyes&#xD;
&#xD;
          7. Preoperative monocular and binocular CDVA equal or better than 0.2 logMAR&#xD;
&#xD;
          8. Normal findings in the medical history and physical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable to meet the limitations of the protocol or likely of non-cooperation&#xD;
             during the trial&#xD;
&#xD;
          2. Patients whose freedom is impaired by administrative or legal order&#xD;
&#xD;
          3. Concurrent participation in another drug or device investigation that affects patients&#xD;
             vision&#xD;
&#xD;
          4. Signs of early cataract in either eye&#xD;
&#xD;
          5. Preoperative monocular and binocular CDVA worse than 0.2 logMAR&#xD;
&#xD;
          6. Clinically significant Posterior capsule opacification (PCO) defined as a CDVA loss of&#xD;
             0.2 logMAR or more in either eye&#xD;
&#xD;
          7. Cataract of any grade&#xD;
&#xD;
          8. Ocular disorders, that could potentially cause future acuity loss to a level of 0.20&#xD;
             logMAR (best-corrected) or worse in either eye&#xD;
&#xD;
          9. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic&#xD;
             uveitis, iritis, aniridia, rubeosis iridis, clinically significant anterior membrane&#xD;
             dystrophies, poor pupil dilation, etc.)&#xD;
&#xD;
         10. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal&#xD;
             degeneration, or irregular astigmatism, clinically significant corneal membrane&#xD;
             dystrophies)&#xD;
&#xD;
         11. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis,&#xD;
             evident zonular weakness or dehiscence, etc.)&#xD;
&#xD;
         12. History of any clinically significant retinal pathology or ocular diagnosis (e.g.&#xD;
             diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment,&#xD;
             optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia,&#xD;
             epiretinal membrane etc.) in the study eyes that could alter or limit final&#xD;
             postoperative visual prognosis.&#xD;
&#xD;
         13. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus&#xD;
&#xD;
         14. Patient expected to require retinal laser treatment before 6 month follow-up visit&#xD;
&#xD;
         15. Patient require refractive laser treatment / refractive laser touch-up before 6 month&#xD;
             follow up visit&#xD;
&#xD;
         16. Current Systemic or ocular pharmacotherapy that effects patients vision&#xD;
&#xD;
         17. Floppy iris syndrome&#xD;
&#xD;
         18. Monophthalmic patient&#xD;
&#xD;
         19. Previous corneal surgery&#xD;
&#xD;
         20. Previous use of cytotoxic drugs or total body irradiation&#xD;
&#xD;
         21. Dementia&#xD;
&#xD;
         22. Uncontrolled glaucoma or Intraocular pressure (IOP) higher than 24 millimeter of&#xD;
             mercury (mmHg) under ocular hypertension treatment&#xD;
&#xD;
         23. Any other pathology or condition presenting, according to the investigator opinion, a&#xD;
             risk for the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Augenzentrum Michelfeld</name>
      <address>
        <city>Michelfeld</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</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>Presbyopia</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/NCT03790592
org study id: LISA tri 839MP BER-401-18
nct id: NCT03790592
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluation of mean preoperative and postoperative Corrected distance visual acuity (CDVA)
      after Refractive Lens Exchange in presbyopic patients
Compare preoperative and postoperative Corrected distance visual acuity
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Corrected distance visual acuity
time frame: 4 to 6 months postop
description: preoperative and postoperative Corrected distance visual acuity will be assessed
arm group label: trifocal IOL
arm group type: Experimental
description: patients implanted with a trifocal intraocular lens
intervention type: Device
intervention name: trifocal IOL
description: intraocular lens
arm group label: trifocal IOL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Presbyopia
sharing ipd: No