<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/NCT03242317</url>
  </required_header>
  <id_info>
    <org_study_id>FEE17-001</org_study_id>
    <nct_id>NCT03242317</nct_id>
  </id_info>
  <brief_title>A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C</brief_title>
  <official_title>A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Treated With Mitomycin C During Surgery and Extended Steroid After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fichte, Endl &amp; Elmer Eyecare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fichte, Endl &amp; Elmer Eyecare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the&#xD;
      improvement of near vision in presbyopes treated with low dose, short duration Mitomycin C&#xD;
      (MMC) during surgery and an extended low dose steroid regimen after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The surgical procedure includes a low dose, short duration MMC treatment on the exposed&#xD;
      stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay.&#xD;
      This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the&#xD;
      stromal bed as well as the stromal side of the corneal flap or pocket. In the third month&#xD;
      after surgical procedure, one-drop a day of low dose steroid will be continued for the&#xD;
      duration of the 24-month follow-up period to maintain corneal health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uncorrected Visual Acuity</measure>
    <time_frame>24 Months</time_frame>
    <description>After the inlay procedure, patients will attain functional near visual acuity in the inlay eye and functional distance acuity binocularly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Corneal Reaction</measure>
    <time_frame>24 Months</time_frame>
    <description>Patients treated with low dose, short duration MMC intraoperatively, then an extended low dose steroid regimen will have minimal levels of corneal reaction.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Mitomycin C + Raindrop Near Vision Inlay</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the Raindrop Near Vision Inlay in Presbyopes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitomycin C</intervention_name>
    <description>The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.</description>
    <arm_group_label>Mitomycin C + Raindrop Near Vision Inlay</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Raindrop Near Vision Inlay</intervention_name>
    <description>The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision.</description>
    <arm_group_label>Mitomycin C + Raindrop Near Vision Inlay</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.&#xD;
&#xD;
        Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye. Patients&#xD;
        have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.&#xD;
&#xD;
        Patients have corrected distance and near visual acuity of 20/25 or better in each eye.&#xD;
&#xD;
        Patients have distance corrected near visual acuity of 20/40 or worse in each eye.&#xD;
&#xD;
        Patients are willing and able to sign and understand a written Informed Consent Form prior&#xD;
        to any study-specific procedures.&#xD;
&#xD;
        Patients are willing and able to return for scheduled follow-up examinations for 24 months&#xD;
        after the corneal inlay surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with prior ocular surgery. Patients with clinically significant dry eye (i.e.,&#xD;
        significant diffuse punctate staining with fluorescein and a tear breakup time less than 8&#xD;
        s) in either eye.&#xD;
&#xD;
        Patients with a planned corneal residual bed thickness that is less than 300 microns&#xD;
        (corneal thickness - (intended ablation depth + intended flap thickness)).&#xD;
&#xD;
        Patients with macular pathology based on dilated fundus exam and/or optical coherence&#xD;
        tomography (OCT) image.&#xD;
&#xD;
        Patients who would be co-managed by an ophthalmologist or optometrist who is not approved&#xD;
        as a ReVision Optics investigator.&#xD;
&#xD;
        Patients with ocular pathology or disease (including pupil pathology such as fixated&#xD;
        pupils) that might confound the outcome or increase the risk of adverse event.&#xD;
&#xD;
        Patients taking systemic or topical medications that might confound the outcome or increase&#xD;
        the risk of adverse event. Patients taking isotretinoin or amiodarone hydrochloride and any&#xD;
        other medication that affects the tear film or accommodation, including but not limited to,&#xD;
        mydriatic, cycloplegic and mitotic agents, tricyclic, phenothiazines, benzodiazepines, and&#xD;
        first generation antihistamines.&#xD;
&#xD;
        Patients with known sensitivity to any planned study medications. Patients with residual,&#xD;
        recurrent, active or uncontrolled eyelid disease. Patients with significant corneal&#xD;
        asymmetry or irregular topography. Patients with clinically significant anterior segment&#xD;
        pathology. Patients with any corneal abnormality, including but not limited to, slit lamp&#xD;
        findings for corneal staining Grade 3 or higher, recurrent corneal erosion or severe&#xD;
        basement membrane disease, and pterygium extending onto the cornea.&#xD;
&#xD;
        Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus&#xD;
        suspect.&#xD;
&#xD;
        Patients with history of Herpes zoster or Herpes simplex keratitis. Patients with any&#xD;
        progressive retinal disease or subjects with a history or evidence of retinal vascular&#xD;
        occlusion and/or hypercoagulability, because of the risks associated with high pressures&#xD;
        during suction application.&#xD;
&#xD;
        Patients with known history of steroid-responsive intraocular pressure increases, glaucoma,&#xD;
        preoperative IOP &gt; 21 mm Hg, or are otherwise suspected of having glaucoma.&#xD;
&#xD;
        Patients with amblyopia or strabismus or those who are at risk for developing strabismus&#xD;
        postoperatively as determined by corneal light reflex and cover-uncover testing.&#xD;
&#xD;
        Patients with diabetic retinopathy, collagen, vascular, diagnosed autoimmune disease (e.g.,&#xD;
        lupus, rheumatoid arthritis, fibromylagia), immunodeficiency (e.g., HIV), connective tissue&#xD;
        disease, or clinically significant atopic syndrome such as allergies or asthma.&#xD;
&#xD;
        Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may&#xD;
        affect wound healing.&#xD;
&#xD;
        Patients with any type of active cancer (ophthalmic or non-ophthalmic). Patients with&#xD;
        uncontrolled infections of any kind. Patients who are pregnant, lactating, of child-bearing&#xD;
        potential and not practicing a medically approved method of birth control, or planning to&#xD;
        become pregnant during the course of the trial, and patients with other conditions&#xD;
        associated with fluctuation of hormones that could lead to refractive changes.&#xD;
&#xD;
        Patients who actively participate in contact sports (i.e., boxing, martial arts) where&#xD;
        impacts to the face and eye are a normal occurrence.&#xD;
&#xD;
        Patients participating in any other ophthalmic or non-ophthalmic drug/device clinical&#xD;
        trials during the time of this clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Endl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fichte, Endl &amp; Elmer Eyecare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael J Endl, MD</last_name>
    <phone>(716) 564-2020</phone>
    <email>mpderme@aol.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fichte Endl &amp; Elmer Eyecare</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14228</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Micheal J Endl, MD</last_name>
      <phone>716-564-2020</phone>
      <email>mpderme@aol.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 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>Presbyopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
  </intervention_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/NCT03242317
org study id: FEE17-001
nct id: NCT03242317
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: Yes
The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the
      improvement of near vision in presbyopes treated with low dose, short duration Mitomycin C
      (MMC) during surgery and an extended low dose steroid regimen after surgery.
The surgical procedure includes a low dose, short duration MMC treatment on the exposed
      stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay.
      This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the
      stromal bed as well as the stromal side of the corneal flap or pocket. In the third month
      after surgical procedure, one-drop a day of low dose steroid will be continued for the
      duration of the 24-month follow-up period to maintain corneal health.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Uncorrected Visual Acuity
time frame: 24 Months
description: After the inlay procedure, patients will attain functional near visual acuity in the inlay eye and functional distance acuity binocularly.
measure: Incidence of Corneal Reaction
time frame: 24 Months
description: Patients treated with low dose, short duration MMC intraoperatively, then an extended low dose steroid regimen will have minimal levels of corneal reaction.
arm group label: Mitomycin C + Raindrop Near Vision Inlay
arm group type: Experimental
description: The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the Raindrop Near Vision Inlay in Presbyopes.
intervention type: Drug
intervention name: Mitomycin C
description: The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.
arm group label: Mitomycin C + Raindrop Near Vision Inlay
intervention type: Device
intervention name: Raindrop Near Vision Inlay
description: The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision.
arm group label: Mitomycin C + Raindrop Near Vision Inlay
criteria: 
gender: All
minimum age: 41 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael J Endl, MD
role: Principal Investigator
affiliation: Fichte, Endl & Elmer Eyecare
last name: Michael J Endl, MD
phone: (716) 564-2020
email: mpderme@aol.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Mitomycins
mesh term: Mitomycin
sharing ipd: No