<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/NCT01695811</url>
  </required_header>
  <id_info>
    <org_study_id>FLAK-15615</org_study_id>
    <nct_id>NCT01695811</nct_id>
  </id_info>
  <brief_title>Femtosecond Laser-Assisted Keratoplasty</brief_title>
  <acronym>FLAK</acronym>
  <official_title>Femtosecond Laser-Assisted Keratoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study will be to determine optimal surgical technique for performing FLAK&#xD;
      including laser parameters, keratoplasty shape and suture technique in order to standardize&#xD;
      surgical technique and to collect safety and efficacy data. This will be compared to data of&#xD;
      patients with full thickness PKP to measure visual outcomes, refraction, astigmatism,&#xD;
      surgical methods and wound healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FLAK Instrument: The Femtosecond Laser (IntraLase Corporation, Irvine, CA) is a focusable&#xD;
      infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (YAG) laser,&#xD;
      but uses shorter pulses in the hundred-femtosecond (100 X 10-15 seconds) duration range.&#xD;
      There is minimal postoperative inflammation and collateral tissue damage.&#xD;
&#xD;
      Subjects: We will be enrolling subjects 18 years or older that need keratoplasty based on&#xD;
      clinical findings. Subjects will be enrolled regardless of race or gender on a first come&#xD;
      first serve basis. Subjects will be recruited from the physicians own clinic.&#xD;
&#xD;
      PKP Subjects: We will do a retrospective chart review on subjects who have undergone&#xD;
      traditional PKP. FLAK eyes will be age and gender matched to these PKP eyes to compare visual&#xD;
      outcomes, wound healing and complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical outcomes</measure>
    <time_frame>1 day, 1 week, 1, 3, 6, 12, 18 and 24 months</time_frame>
    <description>Wound healing, surgical complications, visual function and endothelial layer assessment</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>FLAK</arm_group_label>
    <description>FLAK</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PKP</arm_group_label>
    <description>Retrospective</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        subjects indicated for corneal transplant surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Corneal opacification.&#xD;
&#xD;
          2. Reduced ETDRS-measured, best corrected, distance visual acuity to 20/40 or worse.&#xD;
&#xD;
          3. Ability to participate in follow-up visits..&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Corneal opacification adequately dense to obscure visualization of iris.&#xD;
&#xD;
          2. ETDRS-measured, best-corrected, distance visual acuity of 20/30 or better.&#xD;
&#xD;
          3. Corneal thickness greater than 1200 µm at the 9 mm peripheral zone.&#xD;
&#xD;
          4. Severe corneal thinning including descemetocoele with impending corneal rupture.&#xD;
&#xD;
          5. Prior PKP or incisional surgery that may provide a potential space into which the gas&#xD;
             produced by the procedure can escape.&#xD;
&#xD;
          6. Poor visual potential in the non-study eye (VA of 20/100 or less, without potential&#xD;
             for improvement by the examining ophthalmologist's judgment).&#xD;
&#xD;
          7. History of glaucoma, including steroid response rise in intraocular pressure.&#xD;
&#xD;
          8. Active intraocular inflammation or infection.&#xD;
&#xD;
          9. Age 18 or younger (consideration will be given to an upper age limit).&#xD;
&#xD;
         10. Unable to return for scheduled follow-up examinations.&#xD;
&#xD;
         11. Other medical condition(s) that will likely prevent long term follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>January 16, 2015</last_update_submitted>
  <last_update_submitted_qc>January 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Shahzad Mian</investigator_full_name>
    <investigator_title>Professor, Department of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Keratoconus, PKP, femtosecond laser assisted keratoplasty</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/NCT01695811
org study id: FLAK-15615
nct id: NCT01695811
lead sponsor: 
has dmc: No
The purpose of this study will be to determine optimal surgical technique for performing FLAK
      including laser parameters, keratoplasty shape and suture technique in order to standardize
      surgical technique and to collect safety and efficacy data. This will be compared to data of
      patients with full thickness PKP to measure visual outcomes, refraction, astigmatism,
      surgical methods and wound healing.
FLAK Instrument: The Femtosecond Laser (IntraLase Corporation, Irvine, CA) is a focusable
      infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (YAG) laser,
      but uses shorter pulses in the hundred-femtosecond (100 X 10-15 seconds) duration range.
      There is minimal postoperative inflammation and collateral tissue damage.

      Subjects: We will be enrolling subjects 18 years or older that need keratoplasty based on
      clinical findings. Subjects will be enrolled regardless of race or gender on a first come
      first serve basis. Subjects will be recruited from the physicians own clinic.

      PKP Subjects: We will do a retrospective chart review on subjects who have undergone
      traditional PKP. FLAK eyes will be age and gender matched to these PKP eyes to compare visual
      outcomes, wound healing and complications.
observational model: Case-Control
time perspective: Prospective
measure: Surgical outcomes
time frame: 1 day, 1 week, 1, 3, 6, 12, 18 and 24 months
description: Wound healing, surgical complications, visual function and endothelial layer assessment
arm group label: FLAK
description: FLAK
arm group label: PKP
description: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Shahzad Mian
investigator title: Professor, Department of Ophthalmology
mesh term: Keratoconus