Choroidal Change on OCTA in Eyes With High Myopia

Myopia, Progressive Clinical Trial

Official title:

OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04255524
• Other study ID #: OCTAPPA
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zizong Hu, PhD, MD
• Phone: +8615195960100
• Email: huzizhong[@]njum.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Spherical equivalent measurement can be included in above 4 groups

2. Willing to be followed up in the future 10 years

Exclusion Criteria:

1. Deny to sign the patient consent, or deny to be followed

2. Evidence of cardiac, or diabetic, or CNS disease.

3. Clinically diagnosed with retinal or choroidal disease

4. Glucoma

5. Cataract or corneal disease that influence the quality of fundus OCTA image

Related Conditions & MeSH terms

• Choroid Disease
• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Device:
• Optic coherence tomography angiography (OCTA)
Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parapapillary choroidal microvasculature void (MvV) area	area of parapapillary choroidal microvasculature void on OCTA images	changes of MvV area from at 10 years
Primary	Parapapillary choroidal microvasculature void (MvV) area	area of parapapillary choroidal microvasculature void on OCTA images	difference of MvV area in each group at baseline
Primary	Parapapillary choroidal microvasculature void (MvV) area	area of parapapillary choroidal microvasculature void on OCTA images	changes of MvV area at 1 years
Primary	Parapapillary choroidal microvasculature void (MvV) area	area of parapapillary choroidal microvasculature void on OCTA images	changes of MvV area at 3 years
Primary	Parapapillary choroidal microvasculature void (MvV) area	area of parapapillary choroidal microvasculature void on OCTA images	changes of MvV area at 5 years
Secondary	MvV number	number of choroidal MvV with certain size	baseline
Secondary	Correlation coefficient between choroidal MvV and refractive power	Correlation coefficient between choroidal MvV and refractive power	baseline
Secondary	Correlation coefficient between choroidal MvV and PPA area	Correlation coefficient between choroidal MvV and parapapillary atrophy beta area	baseline
Secondary	Correlation coefficient between choroidal MvV and choroid thickness	Correlation coefficient between choroidal MvV and choroid thickness	baseline
Secondary	Correlation coefficient between choroidal MvV and RNFL thickness	Correlation coefficient between choroidal MvV and RNFL thickness	baseline
Secondary	Correlation coefficient between choroidal MvV and Axial length	Correlation coefficient between choroidal MvV and Axial length	baseline
Secondary	Correlation coefficient between choroidal MvV and retinal parapapillary perfusion	Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images.	baseline
Secondary	Correlation coefficient between choroidal MvV and Macular perfusion	Correlation coefficient between choroidal MvV and Macular perfusion on OCTA images, Retinal parapapillary perfusion with OCTA.	baseline