GlaucomaNCT06190119
Comparison of Aqueous Humor Adipokines in Glaucoma Patients and Healthy Controls
An observational study of Glaucoma and Adipokines, run by Peking University at 1 site in China.
Trial summary
The purpose of this study is to observe whether there are differences in adipokines in the aqueous humor between patients with primary open-angle glaucoma (POAG) and healthy controls Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma, Adipokines
- What is being tested?
- none intervention
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2023to 1 Apr 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: POAG group and Control group are recruited from people who underwnt anti-glaucoma surgery and cataract surgery.
Who may be able to join
- Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).
Who cannot join
- Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
- Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
- History of Ocular Trauma or Inflammation
- Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
- Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
- Presence of any retinal or optic nerve disease other than glaucoma.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191
Chun Zhang, MD/PhD, +8618601031059, zhangc1@yahoo.com
About this study
Official title: Comparative Analysis of Aqueous Humor Adipokines in Patients With Glaucoma and Healthy Controls
The purpose of this study is to observe whether there are differences in adipokines in the aqueous humor between patients with primary open-angle glaucoma (POAG) and healthy controls
Read the detailed description
- Inclusion criteria: Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).
- Exclusion criteria:
- Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
- Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
- History of Ocular Trauma or Inflammation
- Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
- Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
- Presence of any retinal or optic nerve disease other than glaucoma.
- Conditions
- Glaucoma, Adipokines
- Being tested
- none intervention
- Keywords
- Glaucoma；Adipokines；Neuroinflammation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
This study has no intervention
| Study group | Role | What they receive |
|---|---|---|
| POAG Group | POAG patients who underwent filtering surgery, cataract surgery or MIGS. Receives: Other: none intervention | |
| Control Group | Healthy patients who underwent cataract surgery. Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of adipokines in aqueous humor
Aqueous humor samples were assessed for adipokines and inflammatory cytokines by Luminex bead-based multiplex array
Measured: Cross-sectional baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start8 Oct 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Sponsor
- Investigators
- Chun Zhang, Ph.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190119
- Sponsor's protocol ID
- IRB00006761-M2023196
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Aqueous Humor Adipokines in Patients With Glaucoma and Healthy Controls
- ClinicalTrials.gov ID
- NCT06190119
- Acronym / sponsor ID
- IRB00006761-M2023196
- Conditions
- Glaucoma, Adipokines
- Keywords
- Glaucoma；Adipokines；Neuroinflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 5 Jan 2024 (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.
The purpose of this study is to observe whether there are differences in adipokines in the aqueous humor between patients with primary open-angle glaucoma (POAG) and healthy controls
Detailed description
- Inclusion criteria: Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).
- Exclusion criteria:
- Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
- Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
- History of Ocular Trauma or Inflammation
- Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
- Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
- Presence of any retinal or optic nerve disease other than glaucoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAG Group | – | Other: none interventionPOAG patients who underwent filtering surgery, cataract surgery or MIGS. |
| Control Group | – | Other: none interventionHealthy patients who underwent cataract surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- POAG group and Control group are recruited from people who underwnt anti-glaucoma surgery and cataract surgery.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).
Key exclusion criteria (6 listed)
- Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
- Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
- History of Ocular Trauma or Inflammation
- Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
- Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none interventionThis study has no intervention | Other | Control Group, POAG Group |
Primary outcome
Concentration of adipokines in aqueous humor
Time frame: Cross-sectional baseline
Aqueous humor samples were assessed for adipokines and inflammatory cytokines by Luminex bead-based multiplex array
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
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 Glaucoma and Adipokines, 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 1 inclusion and 6 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 5 Jan 2024. 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 Ziyao Xia, M.D. (+8618810838416, emilyhsia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of adipokines in aqueous humor (time frame: Cross-sectional baseline). 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 5 Jan 2024.