<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/NCT04443231</url>
  </required_header>
  <id_info>
    <org_study_id>tch0101</org_study_id>
    <nct_id>NCT04443231</nct_id>
  </id_info>
  <brief_title>Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation</brief_title>
  <official_title>Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To observe the retinal microvascular alteration during 3 months follow-up after Implantable&#xD;
      Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical&#xD;
      coherence tomography angiography (OCTA) analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was&#xD;
      used to image the superficial and deep retinal vascular plexuses before ICL implantation&#xD;
      surgery and at 3 months follow-up. OCTA images were corrected for magnification,&#xD;
      skeletonized, separated the large vessels and partitioned. Retinal microvascular density was&#xD;
      measured by using fractal dimension analysis. The aim of this study was to uncover potential&#xD;
      retinal vascular network alterations induced by ICL implantation surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal microvessels density</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>BCVA was evaluated by decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean refractive spherical equivalent</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>MRSE = Spherical power + 0.5 * Cylindrical power</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>The IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vault</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>The central vault of the ICL (distance from posterior surface of ICL to the crystalline lens) was measured using Optical Coherence Tomography (Visante; Carl Zeiss Meditec, Jena, Germany)</description>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Adolescent</condition>
  <condition>Adult</condition>
  <condition>Human</condition>
  <condition>Male</condition>
  <condition>Female</condition>
  <condition>Follow-up Studies</condition>
  <condition>Prospective Studies</condition>
  <condition>Lens Implantation, Intraocular</condition>
  <condition>Myopia</condition>
  <condition>Phakic Intraocular Lenses</condition>
  <condition>Retinal Vessels</condition>
  <condition>Postoperative Period</condition>
  <condition>Preoperative Period</condition>
  <condition>Tomography, Optical Coherence</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical Coherence Tomography Angiography</intervention_name>
    <description>AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Moderate and high myopia patients, underwent ICL implantation surgery at the Department of&#xD;
        Ophthalmology, Peking University Third Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 45 years old;&#xD;
&#xD;
          -  Binocular myopia, with a refraction of greater than -3 diopters (D);&#xD;
&#xD;
          -  anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) &gt;&#xD;
             2.8 mm;&#xD;
&#xD;
          -  corneal endothelial cell count (cECC) ≥ 2000 cells/mm2;&#xD;
&#xD;
          -  stable refraction at least 1 year before surgery;&#xD;
&#xD;
          -  unsatisfactory vision with contact lenses or spectacles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of intraocular surgery&#xD;
&#xD;
          -  other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye,&#xD;
             etc.)&#xD;
&#xD;
          -  other serious systemic disease (diabetes, uncontrolled hypertension, severe&#xD;
             hyperthyroidism, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Qi, PhD, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.</citation>
    <PMID>15350323</PMID>
  </reference>
  <results_reference>
    <citation>Yang Y, Wang J, Jiang H, Yang X, Feng L, Hu L, Wang L, Lu F, Shen M. Retinal Microvasculature Alteration in High Myopia. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6020-6030. doi: 10.1167/iovs.16-19542.</citation>
    <PMID>27820633</PMID>
  </results_reference>
  <results_reference>
    <citation>Li M, Yang Y, Jiang H, Gregori G, Roisman L, Zheng F, Ke B, Qu D, Wang J. Retinal Microvascular Network and Microcirculation Assessments in High Myopia. Am J Ophthalmol. 2017 Feb;174:56-67. doi: 10.1016/j.ajo.2016.10.018. Epub 2016 Nov 4.</citation>
    <PMID>27818204</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>March 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</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>Myopia</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/NCT04443231
org study id: tch0101
nct id: NCT04443231
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To observe the retinal microvascular alteration during 3 months follow-up after Implantable
      Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical
      coherence tomography angiography (OCTA) analysis.
The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was
      used to image the superficial and deep retinal vascular plexuses before ICL implantation
      surgery and at 3 months follow-up. OCTA images were corrected for magnification,
      skeletonized, separated the large vessels and partitioned. Retinal microvascular density was
      measured by using fractal dimension analysis. The aim of this study was to uncover potential
      retinal vascular network alterations induced by ICL implantation surgery.
observational model: Cohort
time perspective: Prospective
measure: Retinal microvessels density
time frame: 3 months postoperatively
description: Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)
measure: Best corrected visual acuity
time frame: 3 months postoperatively
description: BCVA was evaluated by decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
measure: Mean refractive spherical equivalent
time frame: 3 months postoperatively
description: MRSE = Spherical power + 0.5 * Cylindrical power
measure: Intraocular pressure
time frame: 3 months postoperatively
description: The IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).
measure: Vault
time frame: 3 months postoperatively
description: The central vault of the ICL (distance from posterior surface of ICL to the crystalline lens) was measured using Optical Coherence Tomography (Visante; Carl Zeiss Meditec, Jena, Germany)
intervention type: Device
intervention name: Optical Coherence Tomography Angiography
description: AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Qi, PhD, MD
role: Study Director
affiliation: Peking University Third Hospital
facility: 
country: China
citation: Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.
PMID: 15350323
citation: Yang Y, Wang J, Jiang H, Yang X, Feng L, Hu L, Wang L, Lu F, Shen M. Retinal Microvasculature Alteration in High Myopia. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6020-6030. doi: 10.1167/iovs.16-19542.
PMID: 27820633
citation: Li M, Yang Y, Jiang H, Gregori G, Roisman L, Zheng F, Ke B, Qu D, Wang J. Retinal Microvascular Network and Microcirculation Assessments in High Myopia. Am J Ophthalmol. 2017 Feb;174:56-67. doi: 10.1016/j.ajo.2016.10.018. Epub 2016 Nov 4.
PMID: 27818204
responsible party type: Sponsor
mesh term: Myopia
sharing ipd: No