<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/NCT04430244</url>
  </required_header>
  <id_info>
    <org_study_id>2020001</org_study_id>
    <nct_id>NCT04430244</nct_id>
  </id_info>
  <brief_title>Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas</brief_title>
  <official_title>Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Internazionale di Ricerca e Formazione in Oftalmologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Internazionale di Ricerca e Formazione in Oftalmologia</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>
      The objective of this study is to assess the outcomes between deep anterior lamellar&#xD;
      keratoplasty using dehydrated versus standard organ culture stored donor corneas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Keratoconus is a common corneal disease characterized by progressive thinning and steepening&#xD;
      resulting in significant visual impairment. With improved instrumentation and corneal imaging&#xD;
      technology, deep anterior keratoplasty has been recognized as the preferred primary operative&#xD;
      technique for cases of keratoconus requiring corneal transplantation.&#xD;
&#xD;
      Since corneas preserved through organ culture remain viable only for up to 4 weeks,&#xD;
      techniques that can extend storage of corneas have been explored.&#xD;
&#xD;
      The objective of this study is to assess the outcomes between deep anterior lamellar&#xD;
      keratoplasty using dehydrated versus standard organ culture stored donor corneas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in best spectacle-corrected visual acuity</measure>
    <time_frame>Preoperatively; and 6 and 12 months postoperatively</time_frame>
    <description>Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in astigmatism</measure>
    <time_frame>Preoperatively; and 6 and 12 months postoperatively</time_frame>
    <description>Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Thinnest-point pachymetry</measure>
    <time_frame>Preoperatively; and 6 and 12 months postoperatively</time_frame>
    <description>Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in endothelial cell density</measure>
    <time_frame>Preoperatively; and 6 and 12 months postoperatively</time_frame>
    <description>Measured using noncontact specular microscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of graft rejection</measure>
    <time_frame>6 and 12 months postoperatively</time_frame>
    <description>Clinically assessed during postoperative examinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of graft failure</measure>
    <time_frame>6 and 12 months postoperatively</time_frame>
    <description>Clinically assessed during postoperative examinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal donor loss due to preparation</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Based on intraoperative assessment of corneas unusable for corneal transplantation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Refraction</measure>
    <time_frame>6 and 12 months postoperatively</time_frame>
    <description>Measured by manifest refraction</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events/Complication</measure>
    <time_frame>up to 12 months postoperatively</time_frame>
    <description>Comparison of total rates of adverse events/complications assessed clinically</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>DALK using Dehydrated Corneas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Corneal transplantation of anterior lamellar grafts from dehydrated corneas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DALK using Standard Organ Culture Stored Corneas</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep anterior lamellar keratoplasty</intervention_name>
    <description>Deep anterior lamellar keratoplasty using dehydrated corneas</description>
    <arm_group_label>DALK using Dehydrated Corneas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep anterior lamellar keratoplasty</intervention_name>
    <description>Deep anterior lamellar keratoplasty using standard organ culture stored corneas</description>
    <arm_group_label>DALK using Standard Organ Culture Stored Corneas</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Keratoconus&#xD;
&#xD;
          -  Surgical candidates for deep anterior lamellar keratoplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ocular comorbidities other than cataract (ie. visual significant optic nerve or&#xD;
             macular disease)&#xD;
&#xD;
          -  Previous corneal transplantations or other ocular surgeries except uncomplicated&#xD;
             cataract surgery&#xD;
&#xD;
          -  Inability to comply with study protocol or participate in follow-up visits&#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>Massimo Busin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Ferrara</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Massimo Busin, MD</last_name>
    <phone>+393473448343</phone>
    <email>mbusin@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angeli Christy Yu, MD</last_name>
    <phone>+393663903896</phone>
    <email>angeliyu@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ospedali Privati Forlì &quot;Villa Igea&quot;</name>
      <address>
        <city>Forlì</city>
        <state>Emilia-Romagna</state>
        <zip>47122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Busin, MD</last_name>
      <email>mbusin@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Massimo Busin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 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>Keratoconus</mesh_term>
  </condition_browse>
  <!-- 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/NCT04430244
org study id: 2020001
nct id: NCT04430244
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to assess the outcomes between deep anterior lamellar
      keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Keratoconus is a common corneal disease characterized by progressive thinning and steepening
      resulting in significant visual impairment. With improved instrumentation and corneal imaging
      technology, deep anterior keratoplasty has been recognized as the preferred primary operative
      technique for cases of keratoconus requiring corneal transplantation.

      Since corneas preserved through organ culture remain viable only for up to 4 weeks,
      techniques that can extend storage of corneas have been explored.

      The objective of this study is to assess the outcomes between deep anterior lamellar
      keratoplasty using dehydrated versus standard organ culture stored donor corneas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in best spectacle-corrected visual acuity
time frame: Preoperatively; and 6 and 12 months postoperatively
description: Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
measure: Change in astigmatism
time frame: Preoperatively; and 6 and 12 months postoperatively
description: Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)
measure: Change in Thinnest-point pachymetry
time frame: Preoperatively; and 6 and 12 months postoperatively
description: Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)
measure: Change in endothelial cell density
time frame: Preoperatively; and 6 and 12 months postoperatively
description: Measured using noncontact specular microscopy
measure: Incidence of graft rejection
time frame: 6 and 12 months postoperatively
description: Clinically assessed during postoperative examinations
measure: Incidence of graft failure
time frame: 6 and 12 months postoperatively
description: Clinically assessed during postoperative examinations
measure: Corneal donor loss due to preparation
time frame: Intraoperative
description: Based on intraoperative assessment of corneas unusable for corneal transplantation
measure: Refraction
time frame: 6 and 12 months postoperatively
description: Measured by manifest refraction
measure: Adverse Events/Complication
time frame: up to 12 months postoperatively
description: Comparison of total rates of adverse events/complications assessed clinically
arm group label: DALK using Dehydrated Corneas
arm group type: Experimental
description: Corneal transplantation of anterior lamellar grafts from dehydrated corneas.
arm group label: DALK using Standard Organ Culture Stored Corneas
arm group type: Active Comparator
description: Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.
intervention type: Procedure
intervention name: Deep anterior lamellar keratoplasty
description: Deep anterior lamellar keratoplasty using dehydrated corneas
arm group label: DALK using Dehydrated Corneas
intervention type: Procedure
intervention name: Deep anterior lamellar keratoplasty
description: Deep anterior lamellar keratoplasty using standard organ culture stored corneas
arm group label: DALK using Standard Organ Culture Stored Corneas
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Busin, MD
role: Principal Investigator
affiliation: Università degli Studi di Ferrara
last name: Massimo Busin, MD
phone: +393473448343
email: mbusin@yahoo.com
last name: Angeli Christy Yu, MD
phone: +393663903896
email: angeliyu@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Keratoconus