<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/NCT04447157</url>
  </required_header>
  <id_info>
    <org_study_id>xuwen2020-465</org_study_id>
    <nct_id>NCT04447157</nct_id>
  </id_info>
  <brief_title>The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia</brief_title>
  <official_title>The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      By comparing the preoperative data and postoperative data of 9 patients of microspherophakia,&#xD;
      we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior&#xD;
      chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL&#xD;
      implantation in the surgical treatment of microspherophakia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>Best corrected visual acuity (BCVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>uncorrected distance visual acuity (UDVA) measured using a decimal chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>intraocular pressure measured using non-contact tonometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCIOL tilt degree</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>PCIOL tilt degree measured using Ultrasound biomicroscope</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCIOL decentration distance</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>PCIOL decentration distance measured using Ultrasound biomicroscope</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endothelial cell density</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>Endothelial cell density was measured by specular microscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>6 month postoperation</time_frame>
    <description>Anterior chamber depth measured using Ultrasound biomicroscope</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Microspherophakia</condition>
  <arm_group>
    <arm_group_label>Microspherophakia</arm_group_label>
    <description>This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A retrospective study was conducted on 9 patients (18 eyes) diagnosed with&#xD;
        microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University&#xD;
        School of Medicine from July 2016 to April 2020.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Microspherophakia was diagnosed and lens diameter&lt;9mm;&#xD;
&#xD;
          -  The lens subluxation was beyond the range of one quadrant and glasses cannot correct&#xD;
             the vision;&#xD;
&#xD;
          -  Lens dislocated into the anterior chamber;&#xD;
&#xD;
          -  Lens dislocation caused elevated intraocular pressure (IOP);&#xD;
&#xD;
          -  The lens contacted the corneal endothelium;&#xD;
&#xD;
          -  Cataract;&#xD;
&#xD;
          -  Corneal endothelial cell density&gt;1000/mm2;&#xD;
&#xD;
          -  The fundus was normal without retinal detachment, severe macular disease and optic&#xD;
             nerve atrophy；&#xD;
&#xD;
          -  There was possible improvement in postoperative visual acuity measured by retinometer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The lens is centered and the position of the lens is stable;&#xD;
&#xD;
          -  Glasses can correct the vision obviously;&#xD;
&#xD;
          -  The reason for the elevated IOP was independent with the lens;&#xD;
&#xD;
          -  A high possibility of corneal decompensation after surgery;&#xD;
&#xD;
          -  Fundus function was poor and it is not expected to improve the vision after surgery;&#xD;
&#xD;
          -  Combined with other ocular diseases which were not suitable for IOL implantation;&#xD;
&#xD;
          -  Combined with a systemic disease that the patient cannot tolerate the surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 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>Corneal Diseases</mesh_term>
    <mesh_term>Ectopia Lentis</mesh_term>
    <mesh_term>Glaucoma</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/NCT04447157
org study id: xuwen2020-465
nct id: NCT04447157
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
By comparing the preoperative data and postoperative data of 9 patients of microspherophakia,
      we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior
      chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL
      implantation in the surgical treatment of microspherophakia.
observational model: Case-Only
time perspective: Retrospective
measure: Visual function
time frame: 6 month postoperation
description: Best corrected visual acuity (BCVA) measured using a decimal chart
measure: Visual function
time frame: 6 month postoperation
description: uncorrected distance visual acuity (UDVA) measured using a decimal chart
measure: Intraocular pressure
time frame: 6 month postoperation
description: intraocular pressure measured using non-contact tonometer
measure: PCIOL tilt degree
time frame: 6 month postoperation
description: PCIOL tilt degree measured using Ultrasound biomicroscope
measure: PCIOL decentration distance
time frame: 6 month postoperation
description: PCIOL decentration distance measured using Ultrasound biomicroscope
measure: Endothelial cell density
time frame: 6 month postoperation
description: Endothelial cell density was measured by specular microscopy
measure: Anterior chamber depth
time frame: 6 month postoperation
description: Anterior chamber depth measured using Ultrasound biomicroscope
arm group label: Microspherophakia
description: This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Corneal Diseases
mesh term: Ectopia Lentis
mesh term: Glaucoma