Choroidal Change on OCTA in Eyes With High Myopia

NCT ID: NCT04255524

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2030-12-31

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.

Conditions

Myopia, Progressive; Choroid Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group 1/Control

Spherical equivalent: -2.00～+2.00 D

Group Type: EXPERIMENTAL

Optic coherence tomography angiography (OCTA)

Intervention Type: DEVICE

Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map

Group 1/Myopia

Spherical equivalent: -3.00～-6.00 D

Group Type: EXPERIMENTAL

Optic coherence tomography angiography (OCTA)

Intervention Type: DEVICE

Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map

Group 3/High

Spherical equivalent: -6.00～-10.00 D

Group Type: EXPERIMENTAL

Optic coherence tomography angiography (OCTA)

Intervention Type: DEVICE

Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map

Group 4/Super High

Spherical equivalent: \<-10.00

Group Type: EXPERIMENTAL

Optic coherence tomography angiography (OCTA)

Intervention Type: DEVICE

Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map

Interventions

Optic coherence tomography angiography (OCTA)

Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Zizong Hu, PhD, MD

Role: CONTACT

huzizhong@njum.edu.cn

+8615195960100

Qinghuai Liu, PhD, MD

Role: CONTACT

liuqh@njmu.edu.cn

+8615195960100

Other Identifiers

OCTAPPA

Identifier Type: -

Identifier Source: org_study_id