Three-dimensional Choroidal Vascularity Index in Common Fundus Diseases

Choroid Clinical Trial

Official title:

Changes of Three-dimensional Choroidal Vascular Index by Optical Coherence Tomography in Common Fundus Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790084
• Other study ID #: 3DCVICFD
• Status: Recruiting
• Start date: March 4, 2021
• Est. completion date: March 10, 2024

Study information

• Verified date: March 2021
• Source: Renmin Hospital of Wuhan University
• Contact: CZ Chen, PHD
• Phone: 13072765173
• Email: whuchenchzh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 10, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 75 Years

Eligibility

1. 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

2. 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

3. 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

Related Conditions & MeSH terms

• Choroid

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

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