Clinical Characteristics in Congenital Cataract Eyes | NCT03905044

Studies
Clinical Characteristics in Congenital Cataract Eyes

NCT03905044

Sponsor

yin ying zhao

Status

Completed

Last Update Posted

Apr 5, 2019Actual

Enrollment

239Actual

Phase

Not provided

Conditions

Congenital Cataract

Interventions

eyes with congenital cataracts

Countries

Not provided

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Apr 3, 2019

First Submission Date that Met QC Criteria

Apr 4, 2019

First Posted Date

Apr 5, 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 4, 2019

Last Update Posted Date

Apr 5, 2019Actual

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

This study involved children with congenial cataract eyes, who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were reviewed for primary diagnosis. All surgeries were performed by one experienced surgeon (Z.Y.E) and videos were collected for reviews in details. the clinical data after the surgery were also recorded for further analysis.

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

239Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CC		eyes with congenital cataracts	Other: eyes with congenital cataracts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eyes with congenital cataracts	Other	observation	CC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complication rate	the complication occurrent rate	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with congenital cataracts who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China)

Exclusion Criteria:

ocular trauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children with congenital cataracts

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32280529	Derived	Ding X, Xiang L, Wang Q, Wang D, Chang P, Li Z, Zhao Y, Chu F, Ma C, Zhao YE. Clinical Characteristics and Surgical Safety in Congenital Cataract Eyes with Three Pathological Types of Posterior Capsule Abnormalities. J Ophthalmol. 2020 Mar 16;2020:6958051. doi: 10.1155/2020/6958051. eCollection 2020.

ID	Term
D055537	Light Signal Transduction
D015398	Signal Transduction
D001669	Biochemical Phenomena
D055598	Chemical Phenomena