xml: <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/NCT05964634</url>
    </required_header>
    <id_info>
      <org_study_id>2023KYPJ105</org_study_id>
      <nct_id>NCT05964634</nct_id>
    </id_info>
    <brief_title>Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia</brief_title>
    <official_title>Effect of Peripapillary Atrophy Based on Optical Coherence Tomography to Diagnose Primary Open Angle Glaucoma in High Myopia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongshan Ophthalmic Center, Sun Yat-sen 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>
        This study intends to analyze the characteristics between peripapillary retinal nerve fiber&#xD;
        layer thickness and peripapillary area in high myopia with or without glaucoma&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Glaucoma is the leading cause of irreversible blindness in the world. Myopia is a risk factor&#xD;
        for glaucoma. With the rising prevalence of both myopia and glaucoma in an ageing population,&#xD;
        the occurrence of these two ocular conditions in the same patient is likely to increase. It&#xD;
        was estimated that there were 163 million people who have high myopia in 2000, and the&#xD;
        population with high myopia would increase to almost one billion (9.8% of the world&#xD;
        population) worldwide by 2050.&#xD;
  &#xD;
        There is often a diagnostic challenge to the clinician, since the detection of glaucomatous&#xD;
        optic nerve damage in highly myopic eyes is difficult. Recently, the subclassification of&#xD;
        peripapillary area could potentially be used to differentiate myopic eyes with and without&#xD;
        glaucoma according to OCT findings.&#xD;
  &#xD;
        However, the characteristics of peripapillary atrophy have not been fully applied in the&#xD;
        diagnosis of high myopia and glaucoma.&#xD;
  &#xD;
        In view of the above problems, the purpose of this study is to analyze the peripapillary area&#xD;
        based on optical coherence tomography and it may be a specific marker for identifying high&#xD;
        myopia with primary open angle glaucoma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months</measure>
      <time_frame>1 years</time_frame>
      <description>The circle with a diameter of 3.46 mm is scanned by Spectralis OCT instrument with the optic disc as the center and the RNFL thickness was calculated by built-in software.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of the area of the peripapillary area changes within 12 months</measure>
      <time_frame>1 year</time_frame>
      <description>The results of Spectralis OCT instrument are exported, and used Image J or Spectralis OCT built-in software package to manually locate and measure the area of the temporal parapapillary area</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of the width of the peripapillary area changes within 12 months</measure>
      <time_frame>1 year</time_frame>
      <description>The results of Spectralis OCT instrument are exported, and used Image J or Spectralis OCT built-in software package to manually locate and measure the width of the temporal parapapillary area</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic characteristics</measure>
      <time_frame>1 day of enrollment</time_frame>
      <description>Including but not limited to gender, age, duration of illness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood pressure</measure>
      <time_frame>1 day of enrollment</time_frame>
      <description>Demographic characteristics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>1 day of enrollment</time_frame>
      <description>weight (lb) / [height (in)]2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best corrected visual acuity</measure>
      <time_frame>1 day of enrollment</time_frame>
      <description>Best corrected visual acuity after refractive error correction using the ETDRS chart</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the intraocular pressure changes within 12 mouths</measure>
      <time_frame>1 year</time_frame>
      <description>IOP is measured by goldmann tonometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the visual field changes within 12 mouths</measure>
      <time_frame>1 year</time_frame>
      <description>Assess the degree of visual function damage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Axial length</measure>
      <time_frame>1 day of enrollment</time_frame>
      <description>axial length is measured using A-type ultrasound.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the fundus changes within 12 months</measure>
      <time_frame>1 year</time_frame>
      <description>Fundus photography uses kowa fundus camera</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ocular anterior segment structure</measure>
      <time_frame>1 day of enrollment</time_frame>
      <description>The ocular anterior segment structure uses lit-lamp biomicroscope</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Myopia</condition>
    <condition>Refractive Errors</condition>
    <condition>Eye Diseases</condition>
    <condition>Glaucoma, Primary Open Angle</condition>
    <condition>Peripapillary Atrophy</condition>
    <arm_group>
      <arm_group_label>myopic glaucoma</arm_group_label>
      <description>Patiens who have high myopia with primary open angle glaucoma</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy myopia</arm_group_label>
      <description>Patiens who have high myopia without primary open angle glaucoma</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>OCT imaging</intervention_name>
      <description>Image J or Spectralis OCT built-in software package was used to manually locate and measure the area and width of the temporal parapapillary atrophy.</description>
      <arm_group_label>healthy myopia</arm_group_label>
      <arm_group_label>myopic glaucoma</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who have high myopia with or without glaucoma.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years.&#xD;
  &#xD;
            2. Equivalent spherical ≤-6D or axial length ≥26.5mm.&#xD;
  &#xD;
            3. High myopia with primary open angle glaucoma, such as anterior chamber angle is&#xD;
               opening, optic rim defect, RNFL loss, etc.&#xD;
  &#xD;
            4. The peripapillary region can be accurately defined Based on OCT.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (1) Exclusion criteria for high myopia group:&#xD;
  &#xD;
            1. History of glaucoma and elevated intraocular pressure.&#xD;
  &#xD;
            2. History of uveitis or intraocular surgery.&#xD;
  &#xD;
            3. History of other retinal optic nerve or related systemic diseases.&#xD;
  &#xD;
            4. The examination results are unreliable, such as poor image quality.&#xD;
  &#xD;
          (2) Exclusion criteria for high myopia with primary open angle glaucoma group:&#xD;
  &#xD;
            1. Others nervous system diseases, such as visual field loss or optic nerve damage.&#xD;
  &#xD;
            2. Others non-glaucomatous ocular pathologies may affect the visual field or retinal&#xD;
               nerve fiber layer status, such as retinal diseases, uveitis, or ocular surgery&#xD;
               history.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yiqing Li</last_name>
      <phone>+86 13302235127</phone>
      <email>liyiqing@gzzoc.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jinpeng Yang</last_name>
      <phone>+86 18595813993</phone>
      <email>yangjp35@mail2.sysu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhongshan Ophthalmic Center, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/23462744/</url>
      <description>beta zone and gamma zone defined based on OCT</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/33309588/</url>
      <description>Microstructure of parapapillary atrophy</description>
    </link>
    <reference>
      <citation>Dai Y, Jonas JB, Huang H, Wang M, Sun X. Microstructure of parapapillary atrophy: beta zone and gamma zone. Invest Ophthalmol Vis Sci. 2013 Mar 19;54(3):2013-8. doi: 10.1167/iovs.12-11255.</citation>
      <PMID>23462744</PMID>
    </reference>
    <reference>
      <citation>Wang YX, Panda-Jonas S, Jonas JB. Optic nerve head anatomy in myopia and glaucoma, including parapapillary zones alpha, beta, gamma and delta: Histology and clinical features. Prog Retin Eye Res. 2021 Jul;83:100933. doi: 10.1016/j.preteyeres.2020.100933. Epub 2020 Dec 9.</citation>
      <PMID>33309588</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yiqing Li</investigator_full_name>
      <investigator_title>associate research fellow</investigator_title>
    </responsible_party>
    <keyword>high myopia</keyword>
    <keyword>glaucoma</keyword>
    <keyword>Peripapillary Atrophy</keyword>
    <keyword>Optical Coherence Tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glaucoma</mesh_term>
      <mesh_term>Myopia</mesh_term>
      <mesh_term>Eye Diseases</mesh_term>
      <mesh_term>Refractive Errors</mesh_term>
      <mesh_term>Glaucoma, Open-Angle</mesh_term>
      <mesh_term>Atrophy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964634
  org study id: 2023KYPJ105
  nct id: NCT05964634
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study intends to analyze the characteristics between peripapillary retinal nerve fiber
        layer thickness and peripapillary area in high myopia with or without glaucoma
  Glaucoma is the leading cause of irreversible blindness in the world. Myopia is a risk factor
        for glaucoma. With the rising prevalence of both myopia and glaucoma in an ageing population,
        the occurrence of these two ocular conditions in the same patient is likely to increase. It
        was estimated that there were 163 million people who have high myopia in 2000, and the
        population with high myopia would increase to almost one billion (9.8% of the world
        population) worldwide by 2050.
  
        There is often a diagnostic challenge to the clinician, since the detection of glaucomatous
        optic nerve damage in highly myopic eyes is difficult. Recently, the subclassification of
        peripapillary area could potentially be used to differentiate myopic eyes with and without
        glaucoma according to OCT findings.
  
        However, the characteristics of peripapillary atrophy have not been fully applied in the
        diagnosis of high myopia and glaucoma.
  
        In view of the above problems, the purpose of this study is to analyze the peripapillary area
        based on optical coherence tomography and it may be a specific marker for identifying high
        myopia with primary open angle glaucoma.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months
  time frame: 1 years
  description: The circle with a diameter of 3.46 mm is scanned by Spectralis OCT instrument with the optic disc as the center and the RNFL thickness was calculated by built-in software.
  measure: Evaluation of the area of the peripapillary area changes within 12 months
  time frame: 1 year
  description: The results of Spectralis OCT instrument are exported, and used Image J or Spectralis OCT built-in software package to manually locate and measure the area of the temporal parapapillary area
  measure: Evaluation of the width of the peripapillary area changes within 12 months
  time frame: 1 year
  description: The results of Spectralis OCT instrument are exported, and used Image J or Spectralis OCT built-in software package to manually locate and measure the width of the temporal parapapillary area
  measure: Demographic characteristics
  time frame: 1 day of enrollment
  description: Including but not limited to gender, age, duration of illness
  measure: blood pressure
  time frame: 1 day of enrollment
  description: Demographic characteristics
  measure: BMI
  time frame: 1 day of enrollment
  description: weight (lb) / [height (in)]2
  measure: Best corrected visual acuity
  time frame: 1 day of enrollment
  description: Best corrected visual acuity after refractive error correction using the ETDRS chart
  measure: Evaluation of the intraocular pressure changes within 12 mouths
  time frame: 1 year
  description: IOP is measured by goldmann tonometer.
  measure: Evaluation of the visual field changes within 12 mouths
  time frame: 1 year
  description: Assess the degree of visual function damage
  measure: Axial length
  time frame: 1 day of enrollment
  description: axial length is measured using A-type ultrasound.
  measure: Evaluation of the fundus changes within 12 months
  time frame: 1 year
  description: Fundus photography uses kowa fundus camera
  measure: Ocular anterior segment structure
  time frame: 1 day of enrollment
  description: The ocular anterior segment structure uses lit-lamp biomicroscope
  arm group label: myopic glaucoma
  description: Patiens who have high myopia with primary open angle glaucoma
  arm group label: healthy myopia
  description: Patiens who have high myopia without primary open angle glaucoma
  intervention type: Diagnostic Test
  intervention name: OCT imaging
  description: Image J or Spectralis OCT built-in software package was used to manually locate and measure the area and width of the temporal parapapillary atrophy.
  arm group label: healthy myopia
  arm group label: myopic glaucoma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yiqing Li
  phone: +86 13302235127
  email: liyiqing@gzzoc.com
  last name: Jinpeng Yang
  phone: +86 18595813993
  email: yangjp35@mail2.sysu.edu.cn
  facility: 
  country: China
  url: https://pubmed.ncbi.nlm.nih.gov/23462744/
  description: beta zone and gamma zone defined based on OCT
  url: https://pubmed.ncbi.nlm.nih.gov/33309588/
  description: Microstructure of parapapillary atrophy
  citation: Dai Y, Jonas JB, Huang H, Wang M, Sun X. Microstructure of parapapillary atrophy: beta zone and gamma zone. Invest Ophthalmol Vis Sci. 2013 Mar 19;54(3):2013-8. doi: 10.1167/iovs.12-11255.
  PMID: 23462744
  citation: Wang YX, Panda-Jonas S, Jonas JB. Optic nerve head anatomy in myopia and glaucoma, including parapapillary zones alpha, beta, gamma and delta: Histology and clinical features. Prog Retin Eye Res. 2021 Jul;83:100933. doi: 10.1016/j.preteyeres.2020.100933. Epub 2020 Dec 9.
  PMID: 33309588
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
  investigator full name: Yiqing Li
  investigator title: associate research fellow
  mesh term: Glaucoma
  mesh term: Myopia
  mesh term: Eye Diseases
  mesh term: Refractive Errors
  mesh term: Glaucoma, Open-Angle
  mesh term: Atrophy
  sharing ipd: No