Congenital Cataract With Persistent Fetal Vasculature | NCT03341624

Studies
Congenital Cataract With Persistent Fetal Vasculature

NCT03341624

Sponsor

Yune Zhao

Status

Unknown status

Last Update Posted

Nov 14, 2017Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Persistent Fetal Vasculature
Congenital Cataract

Interventions

cataract surgery cataract extraction and intraocular implantation

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

Nov 2017

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

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Nov 9, 2017

First Submission Date that Met QC Criteria

Nov 9, 2017

First Posted Date

Nov 14, 2017Actual

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

Nov 9, 2017

Last Update Posted Date

Nov 14, 2017Actual

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

To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital.

Detailed Description

methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with PFV who underwent surgical treatment in our hospital were analyzed retrospectively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cataract surgery cataract extraction and intraocular implanta	Experimental		Procedure: cataract surgery cataract extraction and intraocular implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery cataract extraction and intraocular implantation	Procedure		cataract surgery cataract extraction and intraocular implanta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity	level1：visual acuity≥0.3；level 2：0.1≤visual acuity<0.3；level 3：0.02 ≤visual acuity<0.1；level 4：≤0.02	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

congenital cataract with Persistent Fetal Vasculature

Exclusion Criteria:

congenital cataract with no Persistent Fetal Vasculature

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Man Hu, MD	Contact	+86-0571-88185666		64344308@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of Wenzhou Medical College	Recruiting	Wenzhou	Zhejiang	325027	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

Condition Browse Module

MeSH Terms

ID	Term
D054514	Persistent Hyperplastic Primary Vitreous

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided