<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/NCT03752710</url>
  </required_header>
  <id_info>
    <org_study_id>Tianjin LS study</org_study_id>
    <nct_id>NCT03752710</nct_id>
  </id_info>
  <brief_title>Biometry of Occult Lens Subluxation Misdiagnosed as Primary Acute Angle Closed Glaucoma</brief_title>
  <official_title>Biometric Indicators of Eyes With Occult Lens Subluxation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Medical University Eye Hospital</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>
      In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure&#xD;
      which were misdiagnosed as primary angle closure at the first visit, and compared with the&#xD;
      data of chronic angle closure glaucoma, cataract, primary acute angle closure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Eye anterior segment biometry</measure>
    <time_frame>1 day</time_frame>
    <description>Anterior segment biometry measure by Lenstar LS900</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>1 year</time_frame>
    <description>Intraocular pressure was measured by Goldmann tonometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>visual acuity before and after surgery</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">183</enrollment>
  <condition>Subluxation of Lens</condition>
  <arm_group>
    <arm_group_label>Acute primary angle closure</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute secondary angle closure induced by LS</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cataract</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary chronic angle closed glaucoma</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This retrospective case study included 17 eyes of 17 patients with ASAC-LS, who were&#xD;
        misdiagnosed with APACG on their first visit. In addition, 56 eyes of 56 patients diagnosed&#xD;
        with APACG, 54 eyes of 54 patients diagnosed with CPACG, and 56 eyes of 56 patients&#xD;
        diagnosed with cataract were also included. All of the patients were admitted from Jan 10,&#xD;
        2016 to Dec 28, 2017 in Tianjin Medical University Hospital. This study was conducted in&#xD;
        accordance with the Helsinki Declaration and was approved by the Ethics Committee of&#xD;
        Tianjin Medical University Eye Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        ASAC-LS was diagnosed according to the following criteria, including sudden pain in the&#xD;
        eye, decreased vision with or without nausea and vomiting. Slit lamp microscopy reveals&#xD;
        phacodonesis, lens inclination or vitreous herniation into the anterior chamber, central&#xD;
        and peripheral shallow anterior chamber, and asymmetric iris bulge. All patients were&#xD;
        confirmed during the surgery to have LS.&#xD;
&#xD;
        APACG was diagnosed with the following criteria6, 7 8, including substantially elevated IOP&#xD;
        and closed angle, acute eye pain, blurred vision, or nausea and vomiting. More importantly,&#xD;
        ischemic injury caused by acute ocular hypertension, ciliary or mixed congestion, corneal&#xD;
        edema, and glaucoma flecks should be detected.&#xD;
&#xD;
        The diagnostic criteria of CPACG included narrow angle with anterior synechiae of varying&#xD;
        widths, IOP &gt; 22 mmHg, and glaucomatous optic disc damage and visual field shrinkage9-11&#xD;
        The angle closure should be more than two quadrants, yet there was no ischemic injury in&#xD;
        the anterior segment caused by acute ocular hypertension.&#xD;
&#xD;
        Exclusion criteria were history of laser peripheral iridotomy or peripheral iridectomy,&#xD;
        glaucoma filtration surgery, angle closure caused by ocular trauma, uveitis,&#xD;
        neovascularization or lens swelling or hyper mature lens. The patients with acute angle&#xD;
        closure in both eyes were excluded. The subjects in which Lenstar LS900 examination could&#xD;
        not be performed because of severe lens opacity or corneal edema were also not included in&#xD;
        the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin Medical University Eye Hospital</investigator_affiliation>
    <investigator_full_name>Lv Yingjuan</investigator_full_name>
    <investigator_title>Dr Lv Yingjuan</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Lens Subluxation</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/NCT03752710
org study id: Tianjin LS study
nct id: NCT03752710
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure
      which were misdiagnosed as primary angle closure at the first visit, and compared with the
      data of chronic angle closure glaucoma, cataract, primary acute angle closure.
observational model: Case-Control
time perspective: Retrospective
measure: Eye anterior segment biometry
time frame: 1 day
description: Anterior segment biometry measure by Lenstar LS900
measure: Intraocular pressure
time frame: 1 year
description: Intraocular pressure was measured by Goldmann tonometer
measure: visual acuity
time frame: 1 year
description: visual acuity before and after surgery
arm group label: Acute primary angle closure
arm group label: Acute secondary angle closure induced by LS
arm group label: Cataract
arm group label: Primary chronic angle closed glaucoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Tianjin Medical University Eye Hospital
investigator full name: Lv Yingjuan
investigator title: Dr Lv Yingjuan
mesh term: Joint Dislocations
mesh term: Lens Subluxation