<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/NCT03787576</url>
  </required_header>
  <id_info>
    <org_study_id>18/552-E</org_study_id>
    <nct_id>NCT03787576</nct_id>
  </id_info>
  <brief_title>Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens</brief_title>
  <official_title>Relationship Between Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens Implantation and Defocus Curves, Contrast Sensitivity and Photic Phenomena</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clínica Rementería</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clínica Rementería</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies&#xD;
      published up-to-date have focused on visual acuity, but not on patient-reported outcomes.&#xD;
      Since some patients with very good postoperative visual acuity report being very&#xD;
      uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is&#xD;
      correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity,&#xD;
      photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with&#xD;
      bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after&#xD;
      surgery to try to determine the factors that correlate with patient reported outcomes as&#xD;
      evaluated with the Catquest SF-9 questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 23, 2020</completion_date>
  <primary_completion_date type="Actual">December 23, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Three months after surgery</time_frame>
    <description>Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Cataract</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cataract surgery</intervention_name>
    <description>Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have undergone bilateral cataract surgery with bilateral implantation of a&#xD;
        multifocal intraocular lens and who are willing to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous bilateral cataract surgery&#xD;
&#xD;
          -  Bilateral implantation of multifocal intraocular lens&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of ocular pathologies&#xD;
&#xD;
          -  Intra- or postoperative complications&#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>Inés Contreras</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinina Rementería</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clínica Rementería</name>
      <address>
        <city>Madrid</city>
        <zip>28010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Rementeria-Capelo LA, Contreras I, Garcia-Perez JL, Carrillo V, Gros-Otero J, Ruiz-Alcocer J. Tolerance to Residual Refractive Errors After Trifocal and Trifocal Toric Intraocular Lens Implantation. Eye Contact Lens. 2021 Apr 1;47(4):213-218. doi: 10.1097/ICL.0000000000000726.</citation>
    <PMID>33323876</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multifocal intraocular lens</keyword>
  <keyword>Trifocal intraocular lens</keyword>
  <keyword>Extended Depth of Focus Lens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Capsule Opacification</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/NCT03787576
org study id: 18/552-E
nct id: NCT03787576
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies
      published up-to-date have focused on visual acuity, but not on patient-reported outcomes.
      Since some patients with very good postoperative visual acuity report being very
      uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is
      correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity,
      photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with
      bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after
      surgery to try to determine the factors that correlate with patient reported outcomes as
      evaluated with the Catquest SF-9 questionnaire.
observational model: Case-Only
time perspective: Prospective
measure: Patient satisfaction
time frame: Three months after surgery
description: Patient satisfaction with visual outcome three months after surgery as evaluated with the Catquest-9 questionnaire
intervention type: Device
intervention name: Cataract surgery
description: Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Inés Contreras
role: Principal Investigator
affiliation: Clinina Rementería
facility: 
country: Spain
citation: Rementeria-Capelo LA, Contreras I, Garcia-Perez JL, Carrillo V, Gros-Otero J, Ruiz-Alcocer J. Tolerance to Residual Refractive Errors After Trifocal and Trifocal Toric Intraocular Lens Implantation. Eye Contact Lens. 2021 Apr 1;47(4):213-218. doi: 10.1097/ICL.0000000000000726.
PMID: 33323876
responsible party type: Sponsor
mesh term: Cataract
mesh term: Capsule Opacification
sharing ipd: Undecided