<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/NCT03017612</url>
  </required_header>
  <id_info>
    <org_study_id>P13-0064</org_study_id>
    <nct_id>NCT03017612</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects</brief_title>
  <official_title>A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc., Raindrop Near Vision Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ReVision Optics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ReVision Optics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near&#xD;
      Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and&#xD;
      intermediate vision. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a&#xD;
      hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50&#xD;
      D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of&#xD;
      -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision&#xD;
      Inlay will be implanted in the non-dominant eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Presbyopia is a natural outcome of pseudophakic subjects with monofocal or toric intraocular&#xD;
      lenses. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact&#xD;
      lenses, or monovision LASIK, which allows the patient to see near objects. All these options&#xD;
      suffer limitations from the patient perspective. For example, reading glasses can easily be&#xD;
      lost or not conveniently available. Multifocal contact lenses suffer from visual symptoms and&#xD;
      instability due to potential rotation and movement of the contact lenses on the surface of&#xD;
      the cornea. And, successful monovision is generally limited to patients with a history of&#xD;
      successful use of contact lenses for monovision, and even in these eyes, monovision is&#xD;
      associated with a substantial decrease in stereo acuity and contrast sensitivity.&#xD;
&#xD;
      ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and&#xD;
      intermediate vision. The inlay is the same refractive index as the human cornea. The inlay is&#xD;
      placed in the non-dominant eye, centered over the pupil after a corneal flap (LASIK) has been&#xD;
      made. The Raindrop Near Vision Inlay is expected to provide low induction of visual symptoms&#xD;
      and improvement of near and intermediate vision in emmetropic subjects with presbyopia. This&#xD;
      technology may also demonstrate potential clinical utility in bilateral pseudophakic&#xD;
      subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change of inlay from no bevel to bevel design&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preservation of Best Corrected Visual Acuity</measure>
    <time_frame>at 6 months postoperatively and all subsequent time points up to 24 months</time_frame>
    <description>Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D</measure>
    <time_frame>At 6 months postoperatively and all subsequent time points up to 24 months</time_frame>
    <description>Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events</measure>
    <time_frame>During the length of the study, up to 24 months</time_frame>
    <description>Any specific adverse event should occur in less than or equal to 5% of eyes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncorrected Intermediate Visual Acuity</measure>
    <time_frame>at 12 months postoperatively</time_frame>
    <description>75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>Single Arm Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Raindrop Near Vision Inlay</intervention_name>
    <description>A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
    <arm_group_label>Single Arm Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must provide informed consent, have signed the written informed consent form,&#xD;
             and been given a copy.&#xD;
&#xD;
          2. Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add&#xD;
             from +1.50 D to +2.50 D.&#xD;
&#xD;
          3. Subjects must have uncorrected near visual acuity worse than 20/40 and better than&#xD;
             20/200 in the non-dominant eye.&#xD;
&#xD;
          4. Subjects must have an uncorrected distance visual acuity of 20/25 or better in both&#xD;
             eyes.&#xD;
&#xD;
          5. Subjects must have distance and near visual acuity correctable to at least 20/20 in&#xD;
             both eyes.&#xD;
&#xD;
          6. Subjects must have a manifest refraction spherical equivalent (MRSE) between - 0.50&#xD;
             and +1.00 D with no more than 0.75 D of refractive cylinder in the non- dominant eye.&#xD;
&#xD;
          7. Subjects must have a tear break-up time (TBUT) of ≥8 seconds.&#xD;
&#xD;
          8. Subjects must have a central corneal thickness of between 500 and 600 microns in the&#xD;
             non-dominant eye.&#xD;
&#xD;
          9. Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the&#xD;
             non-dominant eye.&#xD;
&#xD;
         10. Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.&#xD;
&#xD;
         11. Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the&#xD;
             non-dominant eye.&#xD;
&#xD;
         12. Subjects must be willing and able to return for scheduled follow-up examinations for&#xD;
             24 months after surgery.&#xD;
&#xD;
         13. Subjects must have documented monovision tolerance.&#xD;
&#xD;
         14. Subjects must have a minimum of 3 months between cataract surgery and implantation of&#xD;
             the Raindrop Near Vision Inlay in the non-dominant eye.&#xD;
&#xD;
         15. Subjects must be able to demonstrate refractive stability after cataract surgery (e.g.&#xD;
             No change in MRSE greater than ± 0.50 D within the last 2 consecutive visits at least&#xD;
             2 months apart) in the non-dominant eye.&#xD;
&#xD;
         16. Subjects must have a clear or open posterior capsule in the non-dominant eye. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or&#xD;
             multifocal intraocular lenses (IOLs) in either eye.&#xD;
&#xD;
             2. Subjects with anterior segment pathology in either eye.&#xD;
&#xD;
             3. Subjects who have worn soft or rigid contact lenses within the past 30 days in the&#xD;
             eye to be treated.&#xD;
&#xD;
             4. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease&#xD;
             (e.g., meibomian gland dysfunction), or any corneal abnormality (including endothelial&#xD;
             dystrophy, guttata, recurrent corneal erosion, etc.) in either eye.&#xD;
&#xD;
             5. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in&#xD;
             either eye.&#xD;
&#xD;
             6. Subjects with distorted or unclear corneal mires on topography maps of the non-&#xD;
             dominant eye.&#xD;
&#xD;
             7. Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.&#xD;
&#xD;
             8. Subjects with macular degeneration, retinal detachment, or any other fundus&#xD;
             pathology that would prevent an acceptable visual outcome in either eye.&#xD;
&#xD;
             9. Subjects who have undergone previous corneal surgery including LASIK surgery in the&#xD;
             non-dominant eye.&#xD;
&#xD;
             10. Subjects with a history of herpes zoster or herpes simplex keratitis.&#xD;
&#xD;
             11. Subjects who have a history of steroid-responsive rise in intraocular pressure,&#xD;
             preoperative IOP &gt; 21 mm Hg, glaucoma, or are a glaucoma suspect in either eye.&#xD;
&#xD;
             12. Subjects with a history of uncontrolled diabetes, autoimmune disease connective&#xD;
             tissue disease, or clinically significant atopic syndrome.&#xD;
&#xD;
             13. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy&#xD;
             that may affect wound healing, and any immunocompromised subjects.&#xD;
&#xD;
             14. Subjects who are using ophthalmic medication(s) other than artificial tears for&#xD;
             treatment of any ocular pathology excluding ocular allergy.&#xD;
&#xD;
             15. Subjects using systemic medications with significant ocular side effects.&#xD;
&#xD;
             16. Subjects with known sensitivity to planned study concomitant medications.&#xD;
&#xD;
             17. Subjects who are participating in any other clinical trial during the course of&#xD;
             this clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger Steinert, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harvard Eye Associates</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Vision</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Vision Institute</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Key-Whitman Eye Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carter Eye Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkhurst-NuVision</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>February 12, 2015</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>October 11, 2017</results_first_submitted>
  <results_first_submitted_qc>February 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2018</results_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Presbyopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Arm Study</title>
          <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm Study</title>
          <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision</title>
        <description>75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better</description>
        <time_frame>12 months postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Study</title>
            <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision</title>
          <description>75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better</description>
          <units>Percentage of Implanted Eyes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </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>
        <type>Secondary</type>
        <title>Preservation of Best Corrected Visual Acuity</title>
        <description>Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40</description>
        <time_frame>at 6 months postoperatively and all subsequent time points up to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Study</title>
            <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
          </group>
        </group_list>
        <measure>
          <title>Preservation of Best Corrected Visual Acuity</title>
          <description>Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40</description>
          <units>Percentage of Implanted Eyes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D</title>
        <description>Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D</description>
        <time_frame>At 6 months postoperatively and all subsequent time points up to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Study</title>
            <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D</title>
          <description>Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D</description>
          <units>Percentage of Implanted Eyes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Adverse Events</title>
        <description>Any specific adverse event should occur in less than or equal to 5% of eyes.</description>
        <time_frame>During the length of the study, up to 24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Study</title>
            <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Adverse Events</title>
          <description>Any specific adverse event should occur in less than or equal to 5% of eyes.</description>
          <units>Occurrence of specific adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intraocular Pressure increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inlay Explant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diffuse Lamellar Keratitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of BCVA due to late onset of haze</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epiretinal Membrane</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Uncorrected Intermediate Visual Acuity</title>
        <description>75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better</description>
        <time_frame>at 12 months postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm Study</title>
            <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</description>
          </group>
        </group_list>
        <measure>
          <title>Uncorrected Intermediate Visual Acuity</title>
          <description>75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better</description>
          <units>Percentage of Implanted Eyes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Arm Study</title>
          <description>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects&#xD;
Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.</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="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization due to triple arthrodesis surgery (secondary to muscular dystrophy)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </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="5" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Increase in intraocular pressure &gt; 10mmHg above baseline</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Inlay explant</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diffuse Lamellar Keratitis (DLK)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Loss of BCVA due to late onset of haze</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Epiretinal Membrane</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </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>The investigator agreed to hold this information in confidence and not to disclose it to any third parties for a period of three years from the date of this agreement, or until this information becomes a matter of public knowledge or until a formal agreement for that purpose has been entered into by the parties.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Tracy Shwaery, Global Clinical Research Manager</name_or_title>
      <organization>Ms.</organization>
      <phone>9497072740 ext 157</phone>
      <email>tshwaery@revisionoptics.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/NCT03017612
org study id: P13-0064
nct id: NCT03017612
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near
      Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and
      intermediate vision. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a
      hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50
      D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of
      -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision
      Inlay will be implanted in the non-dominant eye.
Presbyopia is a natural outcome of pseudophakic subjects with monofocal or toric intraocular
      lenses. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact
      lenses, or monovision LASIK, which allows the patient to see near objects. All these options
      suffer limitations from the patient perspective. For example, reading glasses can easily be
      lost or not conveniently available. Multifocal contact lenses suffer from visual symptoms and
      instability due to potential rotation and movement of the contact lenses on the surface of
      the cornea. And, successful monovision is generally limited to patients with a history of
      successful use of contact lenses for monovision, and even in these eyes, monovision is
      associated with a substantial decrease in stereo acuity and contrast sensitivity.

      ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and
      intermediate vision. The inlay is the same refractive index as the human cornea. The inlay is
      placed in the non-dominant eye, centered over the pupil after a corneal flap (LASIK) has been
      made. The Raindrop Near Vision Inlay is expected to provide low induction of visual symptoms
      and improvement of near and intermediate vision in emmetropic subjects with presbyopia. This
      technology may also demonstrate potential clinical utility in bilateral pseudophakic
      subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision
time frame: 12 months postoperatively
description: 75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better
measure: Preservation of Best Corrected Visual Acuity
time frame: at 6 months postoperatively and all subsequent time points up to 24 months
description: Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40
measure: Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D
time frame: At 6 months postoperatively and all subsequent time points up to 24 months
description: Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D
measure: Occurrence of Adverse Events
time frame: During the length of the study, up to 24 months
description: Any specific adverse event should occur in less than or equal to 5% of eyes.
measure: Uncorrected Intermediate Visual Acuity
time frame: at 12 months postoperatively
description: 75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
arm group label: Single Arm Study
arm group type: Experimental
description: Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects
intervention type: Device
intervention name: Raindrop Near Vision Inlay
description: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
arm group label: Single Arm Study
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Roger Steinert, MD
role: Study Chair
affiliation: Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Presbyopia
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed.
point of contact: 