The Pathogenesis of Human Senile Cataract | NCT03907358

Studies
The Pathogenesis of Human Senile Cataract

NCT03907358

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Apr 9, 2019Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Cataract

Interventions

phacoemulsification

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

Apr 2019

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

Dec 7, 2016Actual

Primary Completion Date

Dec 30, 2019Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Apr 4, 2019

First Submission Date that Met QC Criteria

Apr 6, 2019

First Posted Date

Apr 9, 2019Actual

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

Apr 6, 2019

Last Update Posted Date

Apr 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haidong Zou, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.

Detailed Description

Tissue samples and aqueous humor samples will be collected from each individual patients by cataract surgery. After sample treatment, different techniques will be applied for analysis. And bioinformatics approach is applied for data treatment and analysis.The data of genomics, transcriptomics, and proteomics will be analyzed for study of pathological mechanism of cataract.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cataract in old age			Procedure: phacoemulsification
cataract in young age			Procedure: phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phacoemulsification	Procedure		cataract in old age cataract in young age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterization of miRNA in micro-scale human aqueous humor	method development for miRNA detection in aqueous humor	12 month
Favored amplification recovery via protection-chromatin immunoprecipitation-Seq of human eye tissue samples	low-cell-number epigenome profiling for study of cataract	24 month
Study of cataract by genomics, transcriptomics, and proteomics approaches	detect histone H3 lysine 4 trimethylation (H3K4me3) of aqueous humor of cataract patients by genomics, transcriptomics, and proteomics methods	36 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery.

Exclusion Criteria:

Patients whose cataracts need not be operated
Patients with any contraindications to cataract surgery
Patients are unwilling to undergo cataract surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

94 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with the explicit diagnosis of cataract are willing to undergo cataract surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haidong Zou	Contact	86-21-63240090	6833	zouhaidong@hotmail.com
Bijun Zhu	Contact			judyzhu52@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University	Recruiting	Shanghai		200080	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided