<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/NCT03229239</url>
  </required_header>
  <id_info>
    <org_study_id>20170717</org_study_id>
    <nct_id>NCT03229239</nct_id>
  </id_info>
  <brief_title>Corneal Stroma Implantation for the Treatment of Keratoconus</brief_title>
  <official_title>Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong Eye Hospital</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>
      The purpose of this study is to determine whether corneal stroma implantation is effective in&#xD;
      the treatment of keratoconus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma.&#xD;
      The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc.&#xD;
      The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is&#xD;
      really a very big problem. In this pilot project, investigators would like to study whether&#xD;
      corneal stroma implantation can increase the biomechanics of the cornea, which can, to some&#xD;
      extent, delay the progress of keratoconus. This will allowed us to determine if useful data&#xD;
      can be obtained, and if so, the donor cornea can be greatly saved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">August 11, 2018</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>The best corrected visual acuity of the operated eye</measure>
    <time_frame>1 month after operation</time_frame>
    <description>To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The best corrected visual acuity of the operated eye</measure>
    <time_frame>3 months after operation</time_frame>
    <description>To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The best corrected visual acuity of the operated eye</measure>
    <time_frame>6 months after operation</time_frame>
    <description>To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The best corrected visual acuity of the operated eye</measure>
    <time_frame>12 months after operation</time_frame>
    <description>To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The biomechanics of the operated eye</measure>
    <time_frame>1 month after operation</time_frame>
    <description>To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The biomechanics of the operated eye</measure>
    <time_frame>3 months after operation</time_frame>
    <description>To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The biomechanics of the operated eye</measure>
    <time_frame>6 months after operation</time_frame>
    <description>To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The biomechanics of the operated eye</measure>
    <time_frame>12 months after operation</time_frame>
    <description>To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>corneal stroma implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>implant the corneal stroma to the diseased cornea of keratoconus patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>corneal stroma implantation</intervention_name>
    <description>During the operation,implant the corneal stroma to the diseased cornea of keratoconus.</description>
    <arm_group_label>corneal stroma implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Advanced and completed keratoconus patients&#xD;
&#xD;
          2. Voluntarily signed informed consent&#xD;
&#xD;
          3. No surgery and anesthesia contraindications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute edema of cornea&#xD;
&#xD;
          2. Primary keratoconus patients&#xD;
&#xD;
          3. The patients combined systemic diseases&#xD;
&#xD;
          4. Reject study and follow visit&#xD;
&#xD;
          5. Cannot tolerate surgery or anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weiyun Shi, sponsor</last_name>
    <role>Study Chair</role>
    <affiliation>director of shandong eye hosiptal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mingna Liu, researcher</last_name>
    <phone>8613589089612</phone>
    <email>lmn_2422@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hua Gao, researcher</last_name>
    <phone>8613705312702</phone>
    <email>gaohua100@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shandong Eye Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suxia Li, Doctor</last_name>
      <phone>15854107085</phone>
      <email>ykyykjk@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Weiyun Shi, Doctor</last_name>
      <phone>13953218357</phone>
      <email>weiyunshi@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Hua Gao, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</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>
  <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/NCT03229239
org study id: 20170717
nct id: NCT03229239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether corneal stroma implantation is effective in
      the treatment of keratoconus.
Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma.
      The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc.
      The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is
      really a very big problem. In this pilot project, investigators would like to study whether
      corneal stroma implantation can increase the biomechanics of the cornea, which can, to some
      extent, delay the progress of keratoconus. This will allowed us to determine if useful data
      can be obtained, and if so, the donor cornea can be greatly saved.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The best corrected visual acuity of the operated eye
time frame: 1 month after operation
description: To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
measure: The best corrected visual acuity of the operated eye
time frame: 3 months after operation
description: To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
measure: The best corrected visual acuity of the operated eye
time frame: 6 months after operation
description: To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
measure: The best corrected visual acuity of the operated eye
time frame: 12 months after operation
description: To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
measure: The biomechanics of the operated eye
time frame: 1 month after operation
description: To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
measure: The biomechanics of the operated eye
time frame: 3 months after operation
description: To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
measure: The biomechanics of the operated eye
time frame: 6 months after operation
description: To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
measure: The biomechanics of the operated eye
time frame: 12 months after operation
description: To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
arm group label: corneal stroma implantation
arm group type: Experimental
description: implant the corneal stroma to the diseased cornea of keratoconus patients
intervention type: Procedure
intervention name: corneal stroma implantation
description: During the operation,implant the corneal stroma to the diseased cornea of keratoconus.
arm group label: corneal stroma implantation
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Weiyun Shi, sponsor
role: Study Chair
affiliation: director of shandong eye hosiptal
last name: Mingna Liu, researcher
phone: 8613589089612
email: lmn_2422@126.com
last name: Hua Gao, researcher
phone: 8613705312702
email: gaohua100@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Keratoconus
sharing ipd: Undecided