<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/NCT01695642</url>
  </required_header>
  <id_info>
    <org_study_id>LASIK_00049051</org_study_id>
    <nct_id>NCT01695642</nct_id>
  </id_info>
  <brief_title>Long-term LASIK Follow up Study</brief_title>
  <acronym>LASIK</acronym>
  <official_title>Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser</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>
      Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed&#xD;
      for correction of myopia. There are very few studies that have been performed to evaluate&#xD;
      long-term outcomes after LASIK.&#xD;
&#xD;
      In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability&#xD;
      of visual outcomes and long-term effect on corneal morphology with in vivo confocal&#xD;
      microscopy. Clinical and corneal morphology outcomes will also be compared between patients&#xD;
      who had flaps created with the microkeratome and femtosecond laser.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Volunteers will be eligible for enrollment into the study if have had LASIK surgery for&#xD;
      correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the&#xD;
      microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.&#xD;
&#xD;
      A complete ophthalmic examination and corneal confocal microscopy will be performed. The&#xD;
      study visit will take approximately one hour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare flap creation with mikrokeratome and Intralase</measure>
    <time_frame>8 to 10 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Lasik Eye Surgery</condition>
  <arm_group>
    <arm_group_label>Microkeratome</arm_group_label>
    <description>mechanical microkeratome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intralase</arm_group_label>
    <description>femtosecond laser</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the&#xD;
        Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap&#xD;
        creation between 2002 to 2005.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of&#xD;
             follow up after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roni Shtein, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Kellogg Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 26, 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>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Roni Shtein</investigator_full_name>
    <investigator_title>Assistant Professor of Ophthalmology and Visual Sciences</investigator_title>
  </responsible_party>
  <keyword>lasik, intralase, microkeratome</keyword>
  <!-- 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/NCT01695642
org study id: LASIK_00049051
nct id: NCT01695642
lead sponsor: 
has dmc: No
Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed
      for correction of myopia. There are very few studies that have been performed to evaluate
      long-term outcomes after LASIK.

      In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability
      of visual outcomes and long-term effect on corneal morphology with in vivo confocal
      microscopy. Clinical and corneal morphology outcomes will also be compared between patients
      who had flaps created with the microkeratome and femtosecond laser.
Volunteers will be eligible for enrollment into the study if have had LASIK surgery for
      correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the
      microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.

      A complete ophthalmic examination and corneal confocal microscopy will be performed. The
      study visit will take approximately one hour.
observational model: Cohort
time perspective: Prospective
measure: Compare flap creation with mikrokeratome and Intralase
time frame: 8 to 10 years
arm group label: Microkeratome
description: mechanical microkeratome
arm group label: Intralase
description: femtosecond laser
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Roni Shtein, MD, MS
role: Principal Investigator
affiliation: University of Michigan Kellogg Eye Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Roni Shtein
investigator title: Assistant Professor of Ophthalmology and Visual Sciences