Comparison of Aqueous Humor Adipokines in Glaucoma Patien... | NCT06190119

Studies
Comparison of Aqueous Humor Adipokines in Glaucoma Patients and Healthy Controls

NCT06190119

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Jan 5, 2024Actual

Enrollment

2Estimated

Phase

Not provided

Conditions

Glaucoma
Adipokines

Interventions

none intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Dec 19, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2023

Last Update Posted Date

Jan 5, 2024Actual

Name	Class
Beijing Tongren Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

1. Inclusion criteria: Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).

2. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POAG Group		POAG patients who underwent filtering surgery, cataract surgery or MIGS.	Other: none intervention
Control Group		Healthy patients who underwent cataract surgery.	Other: none intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
none intervention	Other	This study has no intervention	Control Group POAG Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of adipokines in aqueous humor	Aqueous humor samples were assessed for adipokines and inflammatory cytokines by Luminex bead-based multiplex array	Cross-sectional baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

POAG group and Control group are recruited from people who underwnt anti-glaucoma surgery and cataract surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ziyao Xia, M.D.	Contact	+8618810838416		emilyhsia@163.com
Chun Zhang, Ph.D.	Contact	+8618601031059		zhangc1@yahoo.com

Overall Officials

Name	Affiliation	Role
Chun Zhang, Ph.D.	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hosipital	Recruiting	Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases