ChoroidNCT04790084
Three-dimensional Choroidal Vascularity Index in Common Fundus Diseases
An observational study of Choroid, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
Explore the changes of choroidal blood perfusion in common fundus diseases by three-dimensional choroidal vascularity index, an optical coherence tomography (OCT) parameter. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Choroid
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2021to 10 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chinese
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000
CZ Chen, PHD, +86 13072765173, whuchenchzh@163.com
GP Sun, 15827084278, sungongpeng@whu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Choroid
- Being tested
- no intervention
- Keywords
- choroidal vascularity index, fundus disease, choroidal blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy-Myopia-CSC | Cross-sectional study, no intervention, only collecting OCT,OCTA images and other eye parameters of patients. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimensional choroidal vascularity index
Three-dimensional choroidal vascularity index of healthy people and patients with common fundus diseases, based on optical coherence tomography.
Measured: baseline, pre-intervention
Secondary outcomes (1)
Choriocapillaris flow deficits%
Choriocapillaris flow deficits% of healthy people and patients with common fundus diseases, based on optical coherence tomography angiography.
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start4 Mar 2021
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChoroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changzheng Chen, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790084
- Sponsor's protocol ID
- 3DCVICFD
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Three-dimensional Choroidal Vascular Index by Optical Coherence Tomography in Common Fundus Diseases
- ClinicalTrials.gov ID
- NCT04790084
- Acronym / sponsor ID
- 3DCVICFD
- Conditions
- Choroid
- Keywords
- choroidal vascularity index, fundus disease, choroidal blood flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy-Myopia-CSC | – | Other: no interventionCross-sectional study, no intervention, only collecting OCT,OCTA images and other eye parameters of patients. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Healthy-Myopia-CSC |
Primary outcome
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.
1 secondary outcome
Choriocapillaris flow deficits%
Time frame: baseline, pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroid, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CZ Chen, PHD (13072765173, whuchenchzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional choroidal vascularity index (time frame: baseline, pre-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.