<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/NCT03233477</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00006761-2014166</org_study_id>
    <nct_id>NCT03233477</nct_id>
  </id_info>
  <brief_title>Patient Registry of Posner-Schlossman Syndrome</brief_title>
  <official_title>Patient Registry of Posner-Schlossman Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking 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>
      Posner-Schlossman syndrome, or glaucomatocyclitic crisis, is a condition characterized by&#xD;
      recurrent, acute attacks of mild, nongranulomatous, anterior uveitis accompanied by markedly&#xD;
      elevated intraocular pressure. Most of patients are the 20 to 50-year-old young adults, with&#xD;
      unilateral eye involvement. PSS was originally deemed benign, but is now recognized as a&#xD;
      relatively rare cause of chronic secondary glaucoma,especially in patients with recurrent&#xD;
      episodes. This relatively rare disease is likely the result of the infections of a variety of&#xD;
      organisms, and the bulk of literature supports the cytomegalovirus (CMV) as the leading&#xD;
      cause.&#xD;
&#xD;
      This study is an observational study that does not interfere with the normal clinical&#xD;
      diagnosis and treatment process. The investigators in this study focus on observing the&#xD;
      clinical symptoms and outcome of PSS, analyzing the factors that affect the prognosis of PSS,&#xD;
      studying the association of its pathogenesis with the psychological status and the behavioral&#xD;
      types of PSS patients; exploring the relationship between infection (CMV, HSV, Hp) and PSS;&#xD;
      and studying the changes of local and systemic cytokine expression and its significance in&#xD;
      patients with PSS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2014</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>demographic characteristics</measure>
    <time_frame>up to 10 years</time_frame>
    <description>age, sex, education level, systemic disease， mental state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>up to 10 years</time_frame>
    <description>uncorrected visual acuity and best corrected visual acuity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intraocular pressure</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Goldmann</description>
  </primary_outcome>
  <primary_outcome>
    <measure>slit-lamp examination</measure>
    <time_frame>up to 10 years</time_frame>
    <description>anterior segment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fundus photograph</measure>
    <time_frame>up to 10 years</time_frame>
    <description>analysis the morphology of optic nerve head</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OCT</measure>
    <time_frame>up to 10 years</time_frame>
    <description>zess</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual field</measure>
    <time_frame>up to 10 years</time_frame>
    <description>Humphrey visual field</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood serum</measure>
    <time_frame>up to 10 years</time_frame>
    <description>8ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>aqueous humor</measure>
    <time_frame>up to 10 years</time_frame>
    <description>0.2ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tissue</measure>
    <time_frame>in the operation</time_frame>
    <description>iris and&amp; or trabecular meshwork tissue abandoned in the anti-glaucoma operation</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Posner Schlossman Syndrome</condition>
  <arm_group>
    <arm_group_label>Posner-Schlossman Syndrome</arm_group_label>
    <description>Inclusion criteria：&#xD;
Clinical diagnosis of Posner-Schlossman Syndrome&#xD;
Able to communicate with doctor and understand this study&#xD;
Exclusion criteria:&#xD;
Not be able to communicate with doctor and understand this study&#xD;
One or more authorized investigators think he or she will suffer from any severe risks from the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cataract</arm_group_label>
    <description>Inclusion criteria：&#xD;
Clinical diagnosis of age-related cataract&#xD;
Prepare for cataract operation&#xD;
Open angle and intraocular pressure is normally at anytime&#xD;
No family history of glaucoma&#xD;
Exclusion criteria:&#xD;
Patients above 65 years old&#xD;
With Secondary ocular hypertension&#xD;
Have the history of receiving any ophthalmologic operation or anti-viral therapy&#xD;
With diabetes mellitus&#xD;
With autoimmune disease&#xD;
Be receiving any therapy that can influence the virus-infection state and biochemical characteristics of serum and aqueous humor, or have received such therapy before one month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>primary open-angle glaucoma</arm_group_label>
    <description>Inclusion criteria：&#xD;
Both eyes involved&#xD;
Open angle&#xD;
Progressive glaucomatous optic neuropathy&#xD;
Specific visual field loss of glaucoma&#xD;
Intraocular pressure above the up limit of normal people&#xD;
Exclusion criteria:&#xD;
Patients above 65 years old&#xD;
With Secondary ocular hypertension&#xD;
Have the history of receiving any ophthalmologic operation or anti-viral therapy&#xD;
With diabetes mellitus&#xD;
With autoimmune disease&#xD;
Be receiving any therapy that can influence the virus-infection state and biochemical characteristics of serum and aqueous humor, or have received such therapy before one month</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, aqueous humor，iris，trabecular meshwork&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients that visit the Peking University Third Hospital from July 2014 to July&#xD;
        2019 and are diognosed as Posner-Schlossman Syndrome, age-related cataract, or primary&#xD;
        open-angle glaucoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer to take part in this study and sign informed consent by oneself or the&#xD;
             patient's legal representative&#xD;
&#xD;
          -  Clinical diagnosis of Posner-Schlossman Syndrome, age-related cataract, or primary&#xD;
             open-angle glaucoma&#xD;
&#xD;
          -  Live in Beijing, China or being able to visit the Peking University Third Hospital&#xD;
             every year after the beginning of the study or whenever the disease relapses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fit any exclusion criteria of the patient's group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chun Zhang, PHD，MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shushan Li, MD</last_name>
    <phone>0086-135-5237-4266</phone>
    <email>shushan_li@yeah.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hosipital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pro. Zhang, PHD, MD</last_name>
      <phone>0086-186-0103-1059</phone>
      <email>zhangc1@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>October 11, 2020</last_update_submitted>
  <last_update_submitted_qc>October 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Chun Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Posner Schlossman Syndrome</keyword>
  <keyword>cytokine expression</keyword>
  <keyword>cytomegalovirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT03233477
org study id: IRB00006761-2014166
nct id: NCT03233477
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Posner-Schlossman syndrome, or glaucomatocyclitic crisis, is a condition characterized by
      recurrent, acute attacks of mild, nongranulomatous, anterior uveitis accompanied by markedly
      elevated intraocular pressure. Most of patients are the 20 to 50-year-old young adults, with
      unilateral eye involvement. PSS was originally deemed benign, but is now recognized as a
      relatively rare cause of chronic secondary glaucoma,especially in patients with recurrent
      episodes. This relatively rare disease is likely the result of the infections of a variety of
      organisms, and the bulk of literature supports the cytomegalovirus (CMV) as the leading
      cause.

      This study is an observational study that does not interfere with the normal clinical
      diagnosis and treatment process. The investigators in this study focus on observing the
      clinical symptoms and outcome of PSS, analyzing the factors that affect the prognosis of PSS,
      studying the association of its pathogenesis with the psychological status and the behavioral
      types of PSS patients; exploring the relationship between infection (CMV, HSV, Hp) and PSS;
      and studying the changes of local and systemic cytokine expression and its significance in
      patients with PSS.
observational model: Cohort
time perspective: Prospective
measure: demographic characteristics
time frame: up to 10 years
description: age, sex, education level, systemic disease， mental state
measure: visual acuity
time frame: up to 10 years
description: uncorrected visual acuity and best corrected visual acuity
measure: intraocular pressure
time frame: up to 10 years
description: Goldmann
measure: slit-lamp examination
time frame: up to 10 years
description: anterior segment
measure: fundus photograph
time frame: up to 10 years
description: analysis the morphology of optic nerve head
measure: OCT
time frame: up to 10 years
description: zess
measure: visual field
time frame: up to 10 years
description: Humphrey visual field
measure: blood serum
time frame: up to 10 years
description: 8ml
measure: aqueous humor
time frame: up to 10 years
description: 0.2ml
measure: tissue
time frame: in the operation
description: iris and& or trabecular meshwork tissue abandoned in the anti-glaucoma operation
arm group label: Posner-Schlossman Syndrome
description: Inclusion criteria：
Clinical diagnosis of Posner-Schlossman Syndrome
Able to communicate with doctor and understand this study
Exclusion criteria:
Not be able to communicate with doctor and understand this study
One or more authorized investigators think he or she will suffer from any severe risks from the study
arm group label: cataract
description: Inclusion criteria：
Clinical diagnosis of age-related cataract
Prepare for cataract operation
Open angle and intraocular pressure is normally at anytime
No family history of glaucoma
Exclusion criteria:
Patients above 65 years old
With Secondary ocular hypertension
Have the history of receiving any ophthalmologic operation or anti-viral therapy
With diabetes mellitus
With autoimmune disease
Be receiving any therapy that can influence the virus-infection state and biochemical characteristics of serum and aqueous humor, or have received such therapy before one month
arm group label: primary open-angle glaucoma
description: Inclusion criteria：
Both eyes involved
Open angle
Progressive glaucomatous optic neuropathy
Specific visual field loss of glaucoma
Intraocular pressure above the up limit of normal people
Exclusion criteria:
Patients above 65 years old
With Secondary ocular hypertension
Have the history of receiving any ophthalmologic operation or anti-viral therapy
With diabetes mellitus
With autoimmune disease
Be receiving any therapy that can influence the virus-infection state and biochemical characteristics of serum and aqueous humor, or have received such therapy before one month
serum, aqueous humor，iris，trabecular meshwork
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chun Zhang, PHD，MD
role: Study Director
affiliation: Peking University Third Hospital
last name: Shushan Li, MD
phone: 0086-135-5237-4266
email: shushan_li@yeah.net
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Chun Zhang
investigator title: Professor
mesh term: Syndrome