<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/NCT04405882</url>
  </required_header>
  <id_info>
    <org_study_id>L1</org_study_id>
    <nct_id>NCT04405882</nct_id>
  </id_info>
  <brief_title>Cornea Ectasia Excimer Laser Treatment</brief_title>
  <official_title>Combined Technique of Corneal Remodeling to Treat Ectasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bambino Gesù Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bambino Gesù Hospital and Research Institute</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>
      To evaluate efficacy, safety, objective and subjective quality of vision after treatment of&#xD;
      cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal&#xD;
      Remodeling (CCR) and Cross-linking (CXL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background To evaluate efficacy, safety, objective and subjective quality of vision after&#xD;
      treatment of cornea ectasia performed with transepithelial topographic guided laser&#xD;
      simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).&#xD;
&#xD;
      Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years)&#xD;
      affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month&#xD;
      postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity&#xD;
      (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of&#xD;
      vision were evaluated preoperatively and 6 months postoperatively using corneal morphological&#xD;
      irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39&#xD;
      questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>quality of vision</measure>
    <time_frame>preoperatively</time_frame>
    <description>uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of vision</measure>
    <time_frame>preoperatively</time_frame>
    <description>Efficacy and Safety index.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of vision</measure>
    <time_frame>preoperatively</time_frame>
    <description>corneal morphological irregularity index (CMI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of vision</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of vision</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>Efficacy and Safety index.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of vision</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>corneal morphological irregularity index (CMI)</description>
  </primary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>Corneal Ectasia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>topographic guided trans epithelial excimer laser</intervention_name>
    <description>In this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.</description>
    <other_name>corneal cross linking</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eight eyes (2 right and 6 left eyes) of 8 patients, 5 male and 3 female (mean age&#xD;
        31.50±14.73, range 19 to 66 years), affected by cornea ectasia were enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - keratoconus with moderate severity (Amsler-Krumeich stage I-II)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concomitant ocular disease&#xD;
&#xD;
          -  concomitant systemic disease&#xD;
&#xD;
          -  corneal opacities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Luca buzzonetti</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00195</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bambino Gesù Hospital and Research Institute</investigator_affiliation>
    <investigator_full_name>Luca Buzzonetti</investigator_full_name>
    <investigator_title>Head of the Ofthalmology Departement</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</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/NCT04405882
org study id: L1
nct id: NCT04405882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate efficacy, safety, objective and subjective quality of vision after treatment of
      cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal
      Remodeling (CCR) and Cross-linking (CXL).
Background To evaluate efficacy, safety, objective and subjective quality of vision after
      treatment of cornea ectasia performed with transepithelial topographic guided laser
      simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

      Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years)
      affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month
      postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity
      (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of
      vision were evaluated preoperatively and 6 months postoperatively using corneal morphological
      irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39
      questionnaires.
observational model: Cohort
time perspective: Retrospective
measure: quality of vision
time frame: preoperatively
description: uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
measure: quality of vision
time frame: preoperatively
description: Efficacy and Safety index.
measure: quality of vision
time frame: preoperatively
description: corneal morphological irregularity index (CMI)
measure: quality of vision
time frame: 6 months postoperatively
description: uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
measure: quality of vision
time frame: 6 months postoperatively
description: Efficacy and Safety index.
measure: quality of vision
time frame: 6 months postoperatively
description: corneal morphological irregularity index (CMI)
intervention type: Procedure
intervention name: topographic guided trans epithelial excimer laser
description: In this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
other name: corneal cross linking
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 66 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Bambino Gesù Hospital and Research Institute
investigator full name: Luca Buzzonetti
investigator title: Head of the Ofthalmology Departement
mesh term: Dilatation, Pathologic
sharing ipd: No