<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/NCT01686906</url>
  </required_header>
  <id_info>
    <org_study_id>NIIOS-BL-2012</org_study_id>
    <nct_id>NCT01686906</nct_id>
  </id_info>
  <brief_title>Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus</brief_title>
  <official_title>Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Netherlands Institute for Innovative Ocular Surgery</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amnitrans Eyebank Rotterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Netherlands Institute for Innovative Ocular Surgery</source>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to&#xD;
      reduce and stabilize ectasia in eyes with advanced keratoconus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</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>Corneal power</measure>
    <time_frame>2011-2020</time_frame>
    <description>Reduction and stabilizing of the corneal power after Bowman layer graft implantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>2011-2020</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Advanced Keratoconus</condition>
  <arm_group>
    <arm_group_label>Bowman layer graft implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bowman layer graft implantation</intervention_name>
    <description>For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.</description>
    <arm_group_label>Bowman layer graft implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •Advanced keratoconus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Further ophthalmic diseases&#xD;
&#xD;
          -  History of ocular surgery&#xD;
&#xD;
          -  Pregnancy, brest feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerrit RJ Melles, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Netherlands Institute for Innovative Ocular Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Netherlands Institute for Innovative Ocular Surgery</name>
      <address>
        <city>Rotterdam</city>
        <zip>3071 AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.</citation>
    <PMID>25596620</PMID>
  </reference>
  <reference>
    <citation>van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.</citation>
    <PMID>24557359</PMID>
  </reference>
  <reference>
    <citation>Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.</citation>
    <PMID>27362885</PMID>
  </reference>
  <reference>
    <citation>Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.</citation>
    <PMID>26077628</PMID>
  </reference>
  <reference>
    <citation>van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.</citation>
    <PMID>34620767</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Keratoconus</keyword>
  <keyword>Bowman layer</keyword>
  <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/NCT01686906
org study id: NIIOS-BL-2012
nct id: NCT01686906
lead sponsor: 
collaborator: 
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to
      reduce and stabilize ectasia in eyes with advanced keratoconus
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Corneal power
time frame: 2011-2020
description: Reduction and stabilizing of the corneal power after Bowman layer graft implantation
measure: Best corrected visual acuity
time frame: 2011-2020
arm group label: Bowman layer graft implantation
arm group type: Experimental
intervention type: Procedure
intervention name: Bowman layer graft implantation
description: For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.
arm group label: Bowman layer graft implantation
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Gerrit RJ Melles, MD, PhD
role: Principal Investigator
affiliation: Netherlands Institute for Innovative Ocular Surgery
facility: 
country: Netherlands
citation: van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.
PMID: 25596620
citation: van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.
PMID: 24557359
citation: Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.
PMID: 27362885
citation: Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.
PMID: 26077628
citation: van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.
PMID: 34620767
responsible party type: Sponsor
mesh term: Keratoconus