Patient Registry of Posner-Schlossman Syndrome

October 11, 2020 updated by: Chun Zhang, Peking University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hosipital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All the patients that visit the Peking University Third Hospital from July 2014 to July 2019 and are diognosed as Posner-Schlossman Syndrome, age-related cataract, or primary open-angle glaucoma.

Description

Inclusion Criteria:

  • Volunteer to take part in this study and sign informed consent by oneself or the patient's legal representative
  • Clinical diagnosis of Posner-Schlossman Syndrome, age-related cataract, or primary open-angle glaucoma
  • Live in Beijing, China or being able to visit the Peking University Third Hospital every year after the beginning of the study or whenever the disease relapses

Exclusion Criteria:

  • Fit any exclusion criteria of the patient's group

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Posner-Schlossman Syndrome

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
cataract

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
primary open-angle glaucoma

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
demographic characteristics
Time Frame: up to 10 years
age, sex, education level, systemic disease， mental state
up to 10 years
visual acuity
Time Frame: up to 10 years
uncorrected visual acuity and best corrected visual acuity
up to 10 years
intraocular pressure
Time Frame: up to 10 years
Goldmann
up to 10 years
slit-lamp examination
Time Frame: up to 10 years
anterior segment
up to 10 years
fundus photograph
Time Frame: up to 10 years
analysis the morphology of optic nerve head
up to 10 years
OCT
Time Frame: up to 10 years
zess
up to 10 years
visual field
Time Frame: up to 10 years
Humphrey visual field
up to 10 years
blood serum
Time Frame: up to 10 years
8ml
up to 10 years
aqueous humor
Time Frame: up to 10 years
0.2ml
up to 10 years
tissue
Time Frame: in the operation
iris and& or trabecular meshwork tissue abandoned in the anti-glaucoma operation
in the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chun Zhang, PHD,MD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00006761-2014166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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