Posner Schlossman SyndromeNCT03233477
Patient Registry of Posner-Schlossman Syndrome
An observational study of Posner Schlossman Syndrome, run by Peking University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Posner Schlossman Syndrome
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2014to 31 Jul 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Fit any exclusion criteria of the patient's group
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191
Pro. Zhang, PHD, MD, 0086-186-0103-1059, zhangc1@yahoo.com
About this study
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.
- Conditions
- Posner Schlossman Syndrome
- Keywords
- Posner Schlossman Syndrome, cytokine expression, cytomegalovirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
demographic characteristics
age, sex, education level, systemic disease， mental state
Measured: up to 10 years
visual acuity
uncorrected visual acuity and best corrected visual acuity
Measured: up to 10 years
intraocular pressure
Goldmann
Measured: up to 10 years
slit-lamp examination
anterior segment
Measured: up to 10 years
fundus photograph
analysis the morphology of optic nerve head
Measured: up to 10 years
OCT
zess
Measured: up to 10 years
visual field
Humphrey visual field
Measured: up to 10 years
blood serum
8ml
Measured: up to 10 years
aqueous humor
0.2ml
Measured: up to 10 years
tissue
iris and\& or trabecular meshwork tissue abandoned in the anti-glaucoma operation
Measured: in the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start31 Jul 2014
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posner Schlossman SyndromeStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Zhang, Peking University
- Investigators
- Chun Zhang, PHD，MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233477
- Sponsor's protocol ID
- IRB00006761-2014166
- Status last verified
- Oct 2020
- First submitted
- 22 Jul 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry of Posner-Schlossman Syndrome
- ClinicalTrials.gov ID
- NCT03233477
- Acronym / sponsor ID
- IRB00006761-2014166
- Conditions
- Posner Schlossman Syndrome
- Keywords
- Posner Schlossman Syndrome, cytokine expression, cytomegalovirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Fit any exclusion criteria of the patient's group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
demographic characteristics
Time frame: up to 10 years
age, sex, education level, systemic disease， mental state
visual acuity
Time frame: up to 10 years
uncorrected visual acuity and best corrected visual acuity
intraocular pressure
Time frame: up to 10 years
Goldmann
slit-lamp examination
Time frame: up to 10 years
anterior segment
fundus photograph
Time frame: up to 10 years
analysis the morphology of optic nerve head
OCT
Time frame: up to 10 years
zess
visual field
Time frame: up to 10 years
Humphrey visual field
blood serum
Time frame: up to 10 years
8ml
aqueous humor
Time frame: up to 10 years
0.2ml
tissue
Time frame: in the operation
iris and\& or trabecular meshwork tissue abandoned in the anti-glaucoma operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Zhang, PHD，MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posner Schlossman Syndrome, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shushan Li, MD (0086-135-5237-4266, shushan_li@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demographic characteristics (time frame: up to 10 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.