Three-dimensional Choroidal Vascularity Index in Common F... | NCT04790084

Studies
Three-dimensional Choroidal Vascularity Index in Common Fundus Diseases

NCT04790084

Sponsor

Renmin Hospital of Wuhan University

Status

Unknown status

Last Update Posted

Mar 10, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Choroid

Interventions

no intervention

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 4, 2021Actual

Primary Completion Date

Mar 10, 2024Estimated

Completion Date

Mar 10, 2024Estimated

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

Mar 6, 2021

First Posted Date

Mar 10, 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

Mar 6, 2021

Last Update Posted Date

Mar 10, 2021Actual

Description Module

Brief Summary

Explore the changes of choroidal blood perfusion in common fundus diseases by three-dimensional choroidal vascularity index, an optical coherence tomography (OCT) parameter.

Detailed Description

Compared with the choroidal vascularity index on a single OCT image, the three-dimensional choroidal vascularity index can evaluate the choroidal changes of chorioretinal diseases as a whole. In this study, the choroidal changes of patients with common fundus diseases were systematically evaluated by collecting OCT and optical coherence tomography angiography (OCTA) images of patients with common fundus diseases, especially in healthy people, myopic people and patients with central serous chorioretinopathy.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy-Myopia-CSC		Cross-sectional study, no intervention, only collecting OCT,OCTA images and other eye parameters of patients.	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	Healthy-Myopia-CSC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Three-dimensional choroidal vascularity index	Three-dimensional choroidal vascularity index of healthy people and patients with common fundus diseases, based on optical coherence tomography.	baseline, pre-intervention

Secondary Outcomes

Measure	Description	Time Frame
Choriocapillaris flow deficits%	Choriocapillaris flow deficits% of healthy people and patients with common fundus diseases, based on optical coherence tomography angiography.	baseline, pre-intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Healthy participants (1) Inclusion Criteria: 1) without systemic diseases such as diabetes and hypertension 2) best corrected visual acuity BCVA ≥ 1.0 3) aged 18 years or older (2) Exclusion criteria: 1) equivalent spherical refraction between -3 diopters and + 1.0 diopters 2) any visible lesions in the retina, optic nerve, or choroid 3) history of refractive or intraocular surgery
Myopia group (1) Inclusion Criteria: 1) equivalent spherical refraction greater than -0.25 diopters 2) without systemic diseases such as diabetes and hypertension 3) Best corrected visual acuity (BCVA) ≥ 1.0 4) aged 10 years or older (2) Exclusion criteria: 1) history of refractive or intraocular surgery 2) history of laser therapy 3) other systemic diseases that may affect the choroid
Central serous chorioretinopathy (CSC) group (1) Inclusion Criteria: 1) a diagnosis of CSC (2) Exclusion criteria: 1) high myopia or hyperopia (greater than 26 or +3 diopters of refractive error) 3) other systemic diseases that may affect the choroid 4) any other associated retinal pathology 5) history of refractive or intraocular surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Chinese

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CZ Chen, PHD	Contact	13072765173		whuchenchzh@163.com
GP Sun, MD	Contact	15827084278		sungongpeng@whu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renmin Hospital of Wuhan University	Recruiting	Wuhan	Hubei	430000	China