Choroidal Change on OCTA in Eyes With High Myopia

Not Applicable

Not yet recruiting

• Conditions: Choroid Disease; Myopia, Progressive
• Interventions: Device: Optic coherence tomography angiography (OCTA)

• Registration Number: NCT04255524
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-31
• Study Start: 2020-02-01
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3/High	Optic coherence tomography angiography (OCTA)	Spherical equivalent: -6.00～-10.00 D
Group 1/Myopia	Optic coherence tomography angiography (OCTA)	Spherical equivalent: -3.00～-6.00 D
Group 4/Super High	Optic coherence tomography angiography (OCTA)	Spherical equivalent: \<-10.00
Group 1/Control	Optic coherence tomography angiography (OCTA)	Spherical equivalent: -2.00～+2.00 D

Primary Outcome Measures

Name	Time	Method
Parapapillary choroidal microvasculature void (MvV) area	changes of MvV area at 5 years	area of parapapillary choroidal microvasculature void on OCTA images

Secondary Outcome Measures

Name	Time	Method
Correlation coefficient between choroidal MvV and refractive power	baseline	Correlation coefficient between choroidal MvV and refractive power
MvV number	baseline	number of choroidal MvV with certain size
Correlation coefficient between choroidal MvV and RNFL thickness	baseline	Correlation coefficient between choroidal MvV and RNFL thickness
Correlation coefficient between choroidal MvV and Axial length	baseline	Correlation coefficient between choroidal MvV and Axial length
Correlation coefficient between choroidal MvV and retinal parapapillary perfusion	baseline	Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images.
Correlation coefficient between choroidal MvV and choroid thickness	baseline	Correlation coefficient between choroidal MvV and choroid thickness
Correlation coefficient between choroidal MvV and PPA area	baseline	Correlation coefficient between choroidal MvV and parapapillary atrophy beta area
Correlation coefficient between choroidal MvV and Macular perfusion	baseline	Correlation coefficient between choroidal MvV and Macular perfusion on OCTA images, Retinal parapapillary perfusion with OCTA.

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China