OCTA Analysis In Children After Lensectomy | NCT04217772

Studies
OCTA Analysis In Children After Lensectomy

NCT04217772

Sponsor

Wenzhou Medical University

Status

Unknown status

Last Update Posted

Jan 3, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Deprivation Amblyopia

Interventions

Optical Coherence Tomography Angiography

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

Jan 2020

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 1, 2017Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Dec 29, 2019

First Submission Date that Met QC Criteria

Jan 2, 2020

First Posted Date

Jan 3, 2020Actual

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

Jan 2, 2020

Last Update Posted Date

Jan 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yune Zhao, Director of Cataract Department, 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 aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eyes post-lensectomy	Experimental	Eyes of children after cataract surgery	Device: Optical Coherence Tomography Angiography
Healthy Eyes	No Intervention	Eyes of healthy volunteers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography Angiography	Device	A device testing the vascular density in the retina	Eyes post-lensectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Foveal retinal thickness	Foveal retinal thickness in microns	up to 36 months
Area of foveal avascular zone	Area of foveal avascular zone in square microns	up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children after cataract surgery and healthy volunteers

Exclusion Criteria:

presence of corneal opacity preventing detailed imaging
nystagmus
retinal disease,
persistent fetal vasculature
intraocular inflammation,
glaucoma
vitreoretinal surgery
premature birth
neurologic disease
systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhangliang Li, MD	Contact	+8613968832833		lizhangliang0328@126.com

Overall Officials

Name	Affiliation	Role
Yune Zhao, MD	Eye Hospital of WMU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of WMU	Recruiting	Hangzhou	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