<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/NCT03789669</url>
  </required_header>
  <id_info>
    <org_study_id>CHTA-103-FLAP</org_study_id>
    <nct_id>NCT03789669</nct_id>
  </id_info>
  <brief_title>A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface</brief_title>
  <official_title>A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Surgical Vision, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Surgical Vision, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a 2-phase, prospective, open-label, comparative (phase II) study design that was&#xD;
      chosen for the purpose of optimizing the Cheetah settings (phase I), and evaluating the&#xD;
      Cheetah system quality of LASIK flap (phase II).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a 3-month, 2-phase, prospective, multicenter, open-label, comparative (phase&#xD;
      II), randomized (phase II, 1:1 ratio for right and left eyes) study.&#xD;
&#xD;
      The study will be conducted at up to 5 sites and will include up to 30 treated subjects in&#xD;
      phase I and up to 250 treated subjects in phase II to achieve minimum 40 eyes with optimized&#xD;
      settings and additional eye data for further device experience.&#xD;
&#xD;
      Subjects will be enrolled in phase I until Cheetah setting optimization is achieved. After&#xD;
      setting optimization, and upon medical monitor and principal investigator consensus, phase II&#xD;
      of the study may begin.&#xD;
&#xD;
      For phase I, one eye of each subject will be included (worst seeing eye should be preferred).&#xD;
      The investigational Cheetah femtosecond laser and Cheetah patient interface (PI) will be used&#xD;
      on one eye to create a LASIK flap. Refractive correction via corneal ablation with a&#xD;
      commercial excimer laser will be performed at the investigator's discretion, provided there&#xD;
      is at least 1.00 D SE of refractive error. If refractive correction is performed on the study&#xD;
      eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain&#xD;
      untreated.&#xD;
&#xD;
      Once five consecutive phase I subjects show good flap lift, per investigator's evaluation,&#xD;
      central flap thickness within ±10 µm of planned thickness, flap diameter within ±0.5 mm of&#xD;
      planned diameter, and upon medical monitor and principal investigator consensus, phase II may&#xD;
      begin.&#xD;
&#xD;
      In phase II both eyes of each subject will be treated. The investigational Cheetah&#xD;
      femtosecond laser and Cheetah PI will be used on one eye, and commercial iFS femtosecond&#xD;
      laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters&#xD;
      (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The&#xD;
      eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye) and&#xD;
      will be considered the study eye.&#xD;
&#xD;
      Subjects in phase II will undergo refractive correction via corneal ablation on both eyes&#xD;
      using a commercial excimer laser for vision correction (same excimer laser system shall be&#xD;
      used on both eyes).&#xD;
&#xD;
      Over the course of the study, minor prototype device settings/improvements (with no safety&#xD;
      implications and without compromising the clinical validity of the study) may be performed to&#xD;
      optimize the quality of flap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cheetah ease of flap lift</measure>
    <time_frame>Operative day</time_frame>
    <description>Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>surface quality</measure>
    <time_frame>Operative Day</time_frame>
    <description>Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>amount of opaque bubble layer (OBL)</measure>
    <time_frame>Operative Day</time_frame>
    <description>Amount of opaque bubble layer will be graded on a scale of 1-5 relative to Intralase iFS flap.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Refractive Error</condition>
  <arm_group>
    <arm_group_label>Investigational</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In phase I the investigators will use the investigational Cheetah femtosecond laser and Cheetah patient interface (PI) on one eye to create a LASIK flap (worst seeing eye should be preferred). Refractive correction via corneal ablation with a commercial excimer laser will be performed at the discretion of the investigator.If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigational/Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In phase II, both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).&#xD;
Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Investigational</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In phase II, both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).&#xD;
Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cheetah femtosecond laser and Cheetah patient interface</intervention_name>
    <description>Ophthalmic laser surgical system</description>
    <arm_group_label>Investigational</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IntraLase iFS iFS femtosecond laser and patient interface</intervention_name>
    <description>Commercial ophthalmic laser surgical system</description>
    <arm_group_label>Control/Investigational</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cheetah femtosecond laser and cheetah patient interface</intervention_name>
    <description>Ophthalmic laser surgical system</description>
    <arm_group_label>Investigational/Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase I of study&#xD;
&#xD;
        INCLUSION CRITERIA&#xD;
&#xD;
        To be considered for enrollment in phase I of the study, subject must:&#xD;
&#xD;
          -  Sign an informed consent and HIPAA authorization&#xD;
&#xD;
          -  Be at least 18 years of age at the time of study exam&#xD;
&#xD;
          -  Have best corrected vision of 20/50 or worse&#xD;
&#xD;
          -  Be available for all scheduled follow-up visits (see below)&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        Subject will not be eligible to take part in phase I of the study if subject, use or have:&#xD;
&#xD;
          -  Known to be pregnant, breastfeeding or intend to become pregnant during the study.&#xD;
&#xD;
          -  Recent ocular (eye) trauma or eye surgery&#xD;
&#xD;
          -  A history of or active ophthalmic (eye) disease or abnormality&#xD;
&#xD;
          -  Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg,&#xD;
             glaucoma suspect, or are taking medications for these conditions&#xD;
&#xD;
          -  A history or current diagnosis of any of the following medical conditions that could&#xD;
             affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency&#xD;
             disease, ocular herpes; endocrine disorders including, but not limited to unstable&#xD;
             thyroid disorders and diabetes, lupus, and rheumatoid arthritis.&#xD;
&#xD;
          -  Cardiac pacemaker, implanted defibrillator or other implanted electronic device&#xD;
&#xD;
          -  Taking systemic or inhaled medications that may affect wound healing&#xD;
&#xD;
          -  Known sensitivity or inappropriate responsiveness to any of the medications used in&#xD;
             the study&#xD;
&#xD;
          -  Participating in any other clinical study&#xD;
&#xD;
        Phase II of study&#xD;
&#xD;
        INCLUSION CRITERIA&#xD;
&#xD;
        To be considered for enrollment in phase II of the study, subject must:&#xD;
&#xD;
          -  Sign an informed consent and HIPAA authorization&#xD;
&#xD;
          -  Be at least 18 years of age at the time of study exam&#xD;
&#xD;
          -  Have refractive error and be eligible for commercial LASIK treatment&#xD;
&#xD;
          -  Be available for all scheduled follow-up visits (see below)&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        Subject will not be eligible to take part in phase II of the study if subject, use or have:&#xD;
&#xD;
          -  Known to be pregnant, breastfeeding or intend to become pregnant during the study.&#xD;
&#xD;
          -  Recent ocular (eye) trauma or eye surgery&#xD;
&#xD;
          -  A history of or active ophthalmic (eye) disease or abnormality&#xD;
&#xD;
          -  Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg,&#xD;
             glaucoma suspect, or are taking medications for these conditions&#xD;
&#xD;
          -  A history or current diagnosis of any of the following medical conditions that could&#xD;
             affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency&#xD;
             disease, ocular herpes; endocrine disorders including, but not limited to unstable&#xD;
             thyroid disorders and diabetes, lupus, and rheumatoid arthritis.&#xD;
&#xD;
          -  Cardiac pacemaker, implanted defibrillator or other implanted electronic device&#xD;
&#xD;
          -  Taking systemic or inhaled medications that may affect wound healing&#xD;
&#xD;
          -  Known sensitivity or inappropriate responsiveness to any of the medications used in&#xD;
             the study&#xD;
&#xD;
          -  Desire for monovision correction&#xD;
&#xD;
          -  Participating in any other clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnson &amp; Johnson Surgical Vision Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Surgical Vision</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Contact</last_name>
    <phone>+1 714 247-8802</phone>
    <email>DParizad@its.jnj.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Narayana Nethralaya Eye Hospital</name>
      <address>
        <city>Rajajinagar</city>
        <state>Bangalore</state>
        <zip>560010</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Center For Sight</name>
      <address>
        <city>Safdarjung Enclave</city>
        <state>New Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital PTE. LTD.</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>India</country>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</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>Refractive Errors</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03789669
org study id: CHTA-103-FLAP
nct id: NCT03789669
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The study is a 2-phase, prospective, open-label, comparative (phase II) study design that was
      chosen for the purpose of optimizing the Cheetah settings (phase I), and evaluating the
      Cheetah system quality of LASIK flap (phase II).
This study is a 3-month, 2-phase, prospective, multicenter, open-label, comparative (phase
      II), randomized (phase II, 1:1 ratio for right and left eyes) study.

      The study will be conducted at up to 5 sites and will include up to 30 treated subjects in
      phase I and up to 250 treated subjects in phase II to achieve minimum 40 eyes with optimized
      settings and additional eye data for further device experience.

      Subjects will be enrolled in phase I until Cheetah setting optimization is achieved. After
      setting optimization, and upon medical monitor and principal investigator consensus, phase II
      of the study may begin.

      For phase I, one eye of each subject will be included (worst seeing eye should be preferred).
      The investigational Cheetah femtosecond laser and Cheetah patient interface (PI) will be used
      on one eye to create a LASIK flap. Refractive correction via corneal ablation with a
      commercial excimer laser will be performed at the investigator's discretion, provided there
      is at least 1.00 D SE of refractive error. If refractive correction is performed on the study
      eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain
      untreated.

      Once five consecutive phase I subjects show good flap lift, per investigator's evaluation,
      central flap thickness within ±10 µm of planned thickness, flap diameter within ±0.5 mm of
      planned diameter, and upon medical monitor and principal investigator consensus, phase II may
      begin.

      In phase II both eyes of each subject will be treated. The investigational Cheetah
      femtosecond laser and Cheetah PI will be used on one eye, and commercial iFS femtosecond
      laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters
      (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The
      eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye) and
      will be considered the study eye.

      Subjects in phase II will undergo refractive correction via corneal ablation on both eyes
      using a commercial excimer laser for vision correction (same excimer laser system shall be
      used on both eyes).

      Over the course of the study, minor prototype device settings/improvements (with no safety
      implications and without compromising the clinical validity of the study) may be performed to
      optimize the quality of flap.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cheetah ease of flap lift
time frame: Operative day
description: Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap.
measure: surface quality
time frame: Operative Day
description: Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap.
measure: amount of opaque bubble layer (OBL)
time frame: Operative Day
description: Amount of opaque bubble layer will be graded on a scale of 1-5 relative to Intralase iFS flap.
arm group label: Investigational
arm group type: Experimental
description: In phase I the investigators will use the investigational Cheetah femtosecond laser and Cheetah patient interface (PI) on one eye to create a LASIK flap (worst seeing eye should be preferred). Refractive correction via corneal ablation with a commercial excimer laser will be performed at the discretion of the investigator.If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated.
arm group label: Investigational/Control
arm group type: Active Comparator
description: In phase II, both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).
Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).
arm group label: Control/Investigational
arm group type: Active Comparator
description: In phase II, both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).
Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).
intervention type: Device
intervention name: Cheetah femtosecond laser and Cheetah patient interface
description: Ophthalmic laser surgical system
arm group label: Investigational
intervention type: Device
intervention name: IntraLase iFS iFS femtosecond laser and patient interface
description: Commercial ophthalmic laser surgical system
arm group label: Control/Investigational
intervention type: Device
intervention name: Cheetah femtosecond laser and cheetah patient interface
description: Ophthalmic laser surgical system
arm group label: Investigational/Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johnson & Johnson Surgical Vision Clinical Trials
role: Study Director
affiliation: Johnson & Johnson Surgical Vision
last name: Study Contact
phone: +1 714 247-8802
email: DParizad@its.jnj.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: India
country: Singapore
responsible party type: Sponsor
mesh term: Refractive Errors
sharing ipd: No