- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04790084
Three-dimensional Choroidal Vascularity Index in Common Fundus Diseases
March 6, 2021 updated by: Changzheng Chen, Renmin Hospital of Wuhan University
Changes of Three-dimensional Choroidal Vascular Index by Optical Coherence Tomography in Common Fundus Diseases
Explore the changes of choroidal blood perfusion in common fundus diseases by three-dimensional choroidal vascularity index, an optical coherence tomography (OCT) parameter.
Study Overview
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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: CZ Chen, PHD
- Phone Number: 13072765173
- Email: whuchenchzh@163.com
Study Contact Backup
- Name: GP Sun, MD
- Phone Number: 15827084278
- Email: sungongpeng@whu.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Renmin Hospital of Wuhan University
-
Contact:
- CZ Chen, PHD
- Phone Number: +86 13072765173
- Email: whuchenchzh@163.com
-
Contact:
- GP Sun
- Phone Number: 15827084278
- Email: sungongpeng@whu.edu.cn
-
Principal Investigator:
- Zhen Chen, PHD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Chinese
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy-Myopia-CSC
Cross-sectional study, no intervention, only collecting OCT,OCTA images and other eye parameters of patients.
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Three-dimensional choroidal vascularity index
Time Frame: baseline, pre-intervention
|
Three-dimensional choroidal vascularity index of healthy people and patients with common fundus diseases, based on optical coherence tomography.
|
baseline, pre-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Choriocapillaris flow deficits%
Time Frame: baseline, pre-intervention
|
Choriocapillaris flow deficits% of healthy people and patients with common fundus diseases, based on optical coherence tomography angiography.
|
baseline, pre-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2021
Primary Completion (Anticipated)
March 10, 2024
Study Completion (Anticipated)
March 10, 2024
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 6, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Actual)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 6, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 3DCVICFD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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