<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/NCT03011554</url>
  </required_header>
  <id_info>
    <org_study_id>IMT-TES-2016</org_study_id>
    <nct_id>NCT03011554</nct_id>
  </id_info>
  <brief_title>Telescope Exchange Study</brief_title>
  <acronym>TES</acronym>
  <official_title>A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VisionCare, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VisionCare, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is&#xD;
      indicated for monocular implantation to improve vision in eyes of patients at least 65 years&#xD;
      of age with severe to profound vision impairment caused by bilateral central scotomas&#xD;
      associated with end-stage age-related macular degeneration (AMD).&#xD;
&#xD;
      Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular&#xD;
      lens placement are currently contraindicated for telescope surgery.&#xD;
&#xD;
      These patients have no viable therapy available to improve their vision.&#xD;
&#xD;
      The objective of the TES pilot study is to evaluate the safety and effectiveness of&#xD;
      implanting the intraocular telescope for improving vision in patients with bilateral&#xD;
      end-stage age- related macular degeneration who are pseudophakic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Subjects will be followed up for three years post implantation</time_frame>
    <description>All reported adverse events will be summarized by number and percent of occurence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in best corrected distance visual acuity (BCDVA)</measure>
    <time_frame>Subjects will be followed up for three years post implantation</time_frame>
    <description>Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial Cell Density</measure>
    <time_frame>Subjects will be followed up for three years post implantation</time_frame>
    <description>ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Increase in best corrected distance visual acuity (BCDVA)</measure>
    <time_frame>Subjects will be followed up for three years post implantation</time_frame>
    <description>Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Implantable Miniature Telescope (IMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantable Miniature Telescope (IMT)</intervention_name>
    <description>Monocular implantation of the IMT.</description>
    <arm_group_label>Implantable Miniature Telescope (IMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have retinal findings of geographic atrophy or disciform scar with foveal involvement&#xD;
             as determined by FA&#xD;
&#xD;
          -  Be age 65 or older&#xD;
&#xD;
          -  Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart&#xD;
&#xD;
          -  Be pseudophakic in the eye selected for telescope implantation&#xD;
&#xD;
          -  Agree to undergo pre-surgery training with a low vision specialist&#xD;
&#xD;
          -  Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope&#xD;
&#xD;
          -  Agree to participate in postoperative vision training with a low vision specialist.&#xD;
&#xD;
          -  Patients must be able to provide and sign a voluntary informed consent.&#xD;
&#xD;
          -  Patients must not meet any of the exclusion criteria below.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stargardt's macular dystrophy&#xD;
&#xD;
          -  Cognitive impairment that would interfere with the ability to understand instructions,&#xD;
             follow directions, or prevent proper visual training/rehabilitation with the device.&#xD;
&#xD;
          -  Any ophthalmic pathology that compromises fellow-eye peripheral vision&#xD;
&#xD;
          -  A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled&#xD;
             glaucoma, or preoperative IOP &gt;22mmHg while on maximum medication&#xD;
&#xD;
          -  Known sensitivity to planned study concomitant medications.&#xD;
&#xD;
          -  An ocular condition that predisposes the patient to eye rubbing.&#xD;
&#xD;
          -  Patients participating in any other ophthalmic drug or device clinical trial during&#xD;
             the time of this clinical investigation.&#xD;
&#xD;
          -  Operative eye with:&#xD;
&#xD;
               -  Evidence of active CNV or treatment of CNV within 6 months&#xD;
&#xD;
               -  IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.&#xD;
&#xD;
               -  Central anterior chamber depth (ACD) &lt; 3.0 mm; measurement of the ACD should be&#xD;
                  taken from the posterior surface of the cornea (endothelium) to the anterior&#xD;
                  surface of the IOL.&#xD;
&#xD;
               -  Axial length &lt; 21 mm or &gt;27 mm&#xD;
&#xD;
               -  Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between the&#xD;
                  ages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, and&#xD;
                  lower than 1800 cells/mm2 for subjects 75 years old or greater.&#xD;
&#xD;
               -  Corneal stromal or endothelial dystrophies, including guttata&#xD;
&#xD;
               -  History of intraocular or corneal surgery (including DSEK) except cataract&#xD;
                  removal and IOL placement&#xD;
&#xD;
               -  History of complicated cataract surgery&#xD;
&#xD;
               -  Compromised capsular bag (previous YAG posterior capsulotomy, evidence of&#xD;
                  tearing)&#xD;
&#xD;
               -  History of Radial Keratotomy&#xD;
&#xD;
               -  Inflammatory ocular disease&#xD;
&#xD;
               -  Pseudoexfoliation or zonular weakness&#xD;
&#xD;
               -  Diabetic retinopathy&#xD;
&#xD;
               -  Untreated retinal tears&#xD;
&#xD;
               -  Retinal vascular disease&#xD;
&#xD;
               -  Optic nerve disease&#xD;
&#xD;
               -  A history of retinal detachment&#xD;
&#xD;
               -  Intraocular tumor&#xD;
&#xD;
               -  Retinitis pigmentosa&#xD;
&#xD;
               -  Prior or expected ophthalmic related surgery within 30 days preceding telescope&#xD;
                  implantation&#xD;
&#xD;
               -  Any medical or ophthalmic condition that in the opinion of the investigator&#xD;
                  renders the subject unsuitable for participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sumit Garg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Derek Kunimoto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Retinal Consultants of AZ</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carole Schreier</last_name>
    <phone>(408) 329-9134</phone>
    <email>carole@visioncareinc.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diane Gordon</last_name>
    <phone>+972-3-928-4002</phone>
    <email>diane@visioncareinc.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Retinal Consultants of AZ</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronald Hawkins</last_name>
      <phone>602-222-2221</phone>
      <phone_ext>1104</phone_ext>
      <email>rhawkins@retinalconsultantsaz.com</email>
    </contact>
    <investigator>
      <last_name>Derek Kunimoto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC Irvine, Gavin Herbert Eye Institute</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosie Magallon</last_name>
      <phone>949-824-8297</phone>
      <email>rmagallo@uci.edu</email>
    </contact>
    <investigator>
      <last_name>Sumit (Sam) Garg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcia Easterly</last_name>
      <phone>909-558-2732</phone>
      <phone_ext>22732</phone_ext>
      <email>MEasterly@llu.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Rauser, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eye Physicians of Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90808</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marisela Silva</last_name>
      <phone>562-421-2757</phone>
      <email>marisela@eplb.com</email>
    </contact>
    <contact_backup>
      <last_name>Martha Cazares</last_name>
      <phone>(562) 421-2757</phone>
      <email>marthac@eplb.com</email>
    </contact_backup>
    <investigator>
      <last_name>Carlos E Martinez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>James W Donovan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eye Care of San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natasha Ozerskiy</last_name>
      <phone>800-765-2737</phone>
      <phone_ext>133</phone_ext>
      <email>Natasha@EyeCareofSanDiego.com</email>
    </contact>
    <contact_backup>
      <last_name>Kim Holdsworth</last_name>
      <email>KimH@eyecareofsandiego.com</email>
    </contact_backup>
    <investigator>
      <last_name>John Bokosky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orange County Retina</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marinel Casiano</last_name>
      <phone>714-972-8432</phone>
      <email>mcasiano@ocretina.net</email>
    </contact>
    <investigator>
      <last_name>Rajiv Rathod, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sarasota Retina Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peggy Jelemensky</last_name>
      <phone>941-921-5335</phone>
      <phone_ext>232</phone_ext>
      <email>SRQresearch@aol.com</email>
    </contact>
    <investigator>
      <last_name>Marc Levy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan, Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Munira Hussain</last_name>
      <phone>734-647-8397</phone>
      <email>hussain@umich.edu</email>
    </contact>
    <investigator>
      <last_name>Shahzad Mian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Minnesota Eye Consultants</name>
      <address>
        <city>Minnetonka</city>
        <state>Minnesota</state>
        <zip>55305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tessa Hugo</last_name>
      <phone>952-567-6111</phone>
      <email>Tlhugo@mneye.colm</email>
    </contact>
    <contact_backup>
      <last_name>Lindsey Fallenstein</last_name>
      <phone>(952) 567-6111</phone>
      <email>lrfallenstein@mneye.com</email>
    </contact_backup>
    <investigator>
      <last_name>David Hardten, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Associated Eye Care</name>
      <address>
        <city>Stillwater</city>
        <state>Minnesota</state>
        <zip>55082</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Trish Johnson</last_name>
      <phone>651-275-3077</phone>
      <email>pjohnson@associatedeyecare.com</email>
    </contact>
    <investigator>
      <last_name>Stephen S Lane, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. John's Clinic - Eye Specialists. Mercy</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Crystal Trythall</last_name>
      <phone>417-820-7493</phone>
      <email>Crystal.trythall@mercy.net</email>
    </contact>
    <investigator>
      <last_name>Shachar Tauber, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eye Associates of New Mexico Vision Research Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory Ogawa, Dr.</last_name>
      <phone>505-888-5757</phone>
    </contact>
    <contact_backup>
      <last_name>Tegan VandenBosch</last_name>
      <phone>505.348-9393</phone>
      <email>tvandenbosch@lrri.org</email>
    </contact_backup>
    <investigator>
      <last_name>Gregory Ogawa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eye Specialty Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Sanford</last_name>
      <phone>901-685-2200</phone>
      <phone_ext>683</phone_ext>
      <email>MichaelSanford@esg.md</email>
    </contact>
    <investigator>
      <last_name>Subba Gollamudi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cornea Consultants of Texas</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Clark</last_name>
      <phone>817-529-3100</phone>
      <phone_ext>6</phone_ext>
      <email>mclark@corneaconsultantstx.com</email>
    </contact>
    <investigator>
      <last_name>Aaleya Korieshi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>April 25, 2018</last_update_submitted>
  <last_update_submitted_qc>April 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</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>Macular Degeneration</mesh_term>
  </condition_browse>
  <!-- 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/NCT03011554
org study id: IMT-TES-2016
nct id: NCT03011554
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is
      indicated for monocular implantation to improve vision in eyes of patients at least 65 years
      of age with severe to profound vision impairment caused by bilateral central scotomas
      associated with end-stage age-related macular degeneration (AMD).

      Patients with end-stage AMD who have undergone bilateral cataract removal and intraocular
      lens placement are currently contraindicated for telescope surgery.

      These patients have no viable therapy available to improve their vision.

      The objective of the TES pilot study is to evaluate the safety and effectiveness of
      implanting the intraocular telescope for improving vision in patients with bilateral
      end-stage age- related macular degeneration who are pseudophakic.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Adverse events
time frame: Subjects will be followed up for three years post implantation
description: All reported adverse events will be summarized by number and percent of occurence.
measure: Decrease in best corrected distance visual acuity (BCDVA)
time frame: Subjects will be followed up for three years post implantation
description: Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.
measure: Endothelial Cell Density
time frame: Subjects will be followed up for three years post implantation
description: ECD change and % change from preoperative visit will be summarized at each visit starting at 3 months post-op.
measure: Increase in best corrected distance visual acuity (BCDVA)
time frame: Subjects will be followed up for three years post implantation
description: Change in LogMar BCDVA from pre-operative visit will be summarized starting at 1 month post-op.
arm group label: Implantable Miniature Telescope (IMT)
arm group type: Experimental
description: Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD.
intervention type: Device
intervention name: Implantable Miniature Telescope (IMT)
description: Monocular implantation of the IMT.
arm group label: Implantable Miniature Telescope (IMT)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Sumit Garg, MD
role: Principal Investigator
affiliation: University of California, Irvine
last name: Derek Kunimoto, MD
role: Principal Investigator
affiliation: Retinal Consultants of AZ
last name: Carole Schreier
phone: (408) 329-9134
email: carole@visioncareinc.net
last name: Diane Gordon
phone: +972-3-928-4002
email: diane@visioncareinc.net
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration