<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/NCT01713660</url>
  </required_header>
  <id_info>
    <org_study_id>FMTO-105-CCIP</org_study_id>
    <nct_id>NCT01713660</nct_id>
  </id_info>
  <brief_title>Corneal Incisions With the IntraLase iFS Femtosecond Laser System</brief_title>
  <official_title>A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Optics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Optics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.</measure>
    <time_frame>Day 0, Operative (Within 2 hours of incision creation)</time_frame>
    <description>Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgeon Assessment of Workflow</measure>
    <time_frame>Day 0, Operative</time_frame>
    <description>Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Seidel Staining</measure>
    <time_frame>Day 0 (performed immediately post-incision creation), Day 1</time_frame>
    <description>Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>FS Corneal Incisions</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iFS Femtosecond Laser</intervention_name>
    <description>corneal incisions created by the femtosecond laser</description>
    <arm_group_label>FS Corneal Incisions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 21 years of age&#xD;
&#xD;
          -  Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and&#xD;
             posterior chamber intraocular lens (IOL) implantation has been planned&#xD;
&#xD;
          -  Visual potential of 20/25 or better in each study eye following cataract removal and&#xD;
             IOL implantation&#xD;
&#xD;
          -  Clear intraocular media other than cataract&#xD;
&#xD;
          -  Available, willing and capable of complying with examination procedures and follow-up&#xD;
             visits for the duration of the study&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous intraocular or corneal surgery, including refractive surgery in the operative&#xD;
             eye(s)&#xD;
&#xD;
          -  History of active or recurrent ophthalmic disease&#xD;
&#xD;
          -  Abnormal topography, including evidence of keratoconus or pellucid marginal&#xD;
             degeneration or irregular astigmatism in the operative eye(s)&#xD;
&#xD;
          -  White to white measurement less than 10 mm or greater than 14 mm&#xD;
&#xD;
          -  Corneal pathology/abnormality that may interfere with the transmission of laser&#xD;
             energy, laser light or precludes applanation&#xD;
&#xD;
          -  Corneal pathology/abnormality that is predicted to cause visual acuity losses to a&#xD;
             level of 20/30 (Snellen) or worse during the study&#xD;
&#xD;
          -  Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal&#xD;
             pathology) that are predicted to cause visual acuity losses to a level of 20/30&#xD;
             (Snellen) or worse during the study&#xD;
&#xD;
          -  Subjects with conditions associated with increased risk of IOL/capsule instability&#xD;
&#xD;
          -  Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil&#xD;
             abnormalities&#xD;
&#xD;
          -  Prior, current, or anticipated use during the course of the study of tamsulosin,&#xD;
             silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)&#xD;
&#xD;
          -  History of any ocular or medical conditions that could affect corneal wound healing&#xD;
&#xD;
          -  Poorly-controlled diabetes or subjects with diabetic retinopathy&#xD;
&#xD;
          -  Concurrent use of topical or systemic medications that may impair corneal wound&#xD;
             healing&#xD;
&#xD;
          -  Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in&#xD;
             the opinion of the investigator, increase the operative risk or confound the&#xD;
             outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)&#xD;
&#xD;
          -  Ocular hypertension (&gt; 21 mm Hg)&#xD;
&#xD;
          -  Women who are pregnant, breast-feeding, or intend to become pregnant over the course&#xD;
             of the study&#xD;
&#xD;
          -  Known sensitivity or inappropriate responsiveness to any of the medications used in&#xD;
             the post operative course&#xD;
&#xD;
          -  Concurrent participation or participation in any other clinical trial during the&#xD;
             duration of this clinical study including 30 days prior to preoperative visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eye Surgeons of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Eye Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>April 5, 2013</results_first_submitted>
  <results_first_submitted_qc>April 5, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 29, 2013</results_first_posted>
  <last_update_submitted>June 4, 2013</last_update_submitted>
  <last_update_submitted_qc>June 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cataract surgery</keyword>
  <keyword>Femtosecond laser</keyword>
  <keyword>Corneal incisions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from private medical practices from October to December 2012</recruitment_details>
      <pre_assignment_details>No preassignment details</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FS Corneal Incisions</title>
          <description>iFS Femtosecond Laser : corneal incisions created by the femtosecond laser</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FS Corneal Incisions</title>
          <description>iFS Femtosecond Laser : corneal incisions created by the femtosecond laser</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.</title>
        <description>Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).</description>
        <time_frame>Day 0, Operative (Within 2 hours of incision creation)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FS Corneal Incisions</title>
            <description>iFS Femtosecond Laser : corneal incisions created by the femtosecond laser</description>
          </group>
        </group_list>
        <measure>
          <title>Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.</title>
          <description>Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Achieved Clear Corneal Incision (CCI) Measurement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intended CCI Incision Size (as programmed)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.74" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgeon Assessment of Workflow</title>
        <description>Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?</description>
        <time_frame>Day 0, Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FS Corneal Incisions</title>
            <description>iFS Femtosecond Laser : corneal incisions created by the femtosecond laser</description>
          </group>
        </group_list>
        <measure>
          <title>Surgeon Assessment of Workflow</title>
          <description>Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?</description>
          <units>percentage of yes answers</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Seidel Staining</title>
        <description>Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.</description>
        <time_frame>Day 0 (performed immediately post-incision creation), Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FS Corneal Incisions</title>
            <description>iFS Femtosecond Laser : corneal incisions created by the femtosecond laser</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Seidel Staining</title>
          <description>Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.</description>
          <units>percentage of eyes with negative Seidel</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>eyes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The time frame for reporting adverse event reports was 1 month.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FS Corneal Incisions</title>
          <description>iFS Femtosecond Laser : corneal incisions created by the femtosecond laser</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Clinical Trial Agreement including &quot;Neither Institution nor Principal Investigator shall have any right to publish or present any information or results concerning the Study without express written consent of Sponsor. Under no circumstances shall Institution or Principal Investigator publish or disclose any of Sponsor's proprietary information, as defined by the CDAs, without Sponsor's prior written approval.&quot;</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Carrie Garufis</name_or_title>
      <organization>AMO</organization>
      <phone>7145663728</phone>
      <email>carrie.garufis@amo.abbott.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01713660
org study id: FMTO-105-CCIP
nct id: NCT01713660
lead sponsor: 
has dmc: No
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract
      surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
time frame: Day 0, Operative (Within 2 hours of incision creation)
description: Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).
measure: Surgeon Assessment of Workflow
time frame: Day 0, Operative
description: Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?
measure: Percent of Seidel Staining
time frame: Day 0 (performed immediately post-incision creation), Day 1
description: Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.
arm group label: FS Corneal Incisions
arm group type: Other
intervention type: Device
intervention name: iFS Femtosecond Laser
description: corneal incisions created by the femtosecond laser
arm group label: FS Corneal Incisions
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Surgical Wound
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 