Analysis of Related Factors Affecting the Secondary Impla... | NCT04824963

Studies
Analysis of Related Factors Affecting the Secondary Implantation of Intraocular Lens in Congenital Cataract

NCT04824963

Sponsor

Wenzhou Medical University

Status

Unknown status

Last Update Posted

Jun 23, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Congenital Cataract

Interventions

Not provided

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

Mar 2021

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

Mar 27, 2021Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Mar 27, 2021

First Submission Date that Met QC Criteria

Mar 27, 2021

First Posted Date

Apr 1, 2021Actual

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

Jun 22, 2021

Last Update Posted Date

Jun 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Wenzhou Medical UniversityOTHER

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

The ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pupil diameter	preoperative pupil diameter size	Before lens implantation
posterior capsule diameter	preoperative posterior capsule diameter size	Before lens implantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were diagnosed as congenital cataract without lens after surgery
Secondare IOLs implantation surgery was performed in Eye hospital of Wenzhou Medical University

Exclusion Criteria:

Suffers from uveitis, glaucoma and other ocular diseases

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

Congenital cataract patient accepted secondary IOLs implantation at Eye hospital of Wenzhou Medical University.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yune Zhao	Contact	+86 13819707056		zyehzeye@126.com
Ziyi Lu	Contact	+86 15157759880		937491851@qq.com

Overall Officials

Name	Affiliation	Role
Yune Zhao	Ophthalmology and Optometry Hospital	Study Director

Locations

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