Choroidal Change on OCTA in Eyes With High Myopia

Study Overview
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Brief Summary
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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.

Official Title
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OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia

Conditions
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Myopia, Progressive, Choroid Disease

Intervention / Treatment
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* Device: Optic coherence tomography angiography (OCTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spherical equivalent measurement can be included in above 4 groups Willing to be followed up in the future 10 years Exclusion Criteria: Deny to sign the patient consent, or deny to be followed Evidence of cardiac, or diabetic, or CNS disease. Clinically diagnosed with retinal or choroidal disease Glucoma Cataract or corneal disease that influence the quality of fundus OCTA image

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1/Control<br>Spherical equivalent: -2.00～+2.00 D | Device: Optic coherence tomography angiography (OCTA)<br>* Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map<br>|
| Experimental: Group 1/Myopia<br>Spherical equivalent: -3.00～-6.00 D | Device: Optic coherence tomography angiography (OCTA)<br>* Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map<br>|
| Experimental: Group 3/High<br>Spherical equivalent: -6.00～-10.00 D | Device: Optic coherence tomography angiography (OCTA)<br>* Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map<br>|
| Experimental: Group 4/Super High<br>Spherical equivalent: <-10.00 | Device: Optic coherence tomography angiography (OCTA)<br>* Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parapapillary choroidal microvasculature void (MvV) area | area of parapapillary choroidal microvasculature void on OCTA images | changes of MvV area from at 10 years | 
| Parapapillary choroidal microvasculature void (MvV) area | area of parapapillary choroidal microvasculature void on OCTA images | difference of MvV area in each group at baseline | 
| Parapapillary choroidal microvasculature void (MvV) area | area of parapapillary choroidal microvasculature void on OCTA images | changes of MvV area at 1 years | 
| Parapapillary choroidal microvasculature void (MvV) area | area of parapapillary choroidal microvasculature void on OCTA images | changes of MvV area at 3 years | 
| Parapapillary choroidal microvasculature void (MvV) area | area of parapapillary choroidal microvasculature void on OCTA images | changes of MvV area at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MvV number | number of choroidal MvV with certain size | baseline | 
| Correlation coefficient between choroidal MvV and refractive power | Correlation coefficient between choroidal MvV and refractive power | baseline | 
| Correlation coefficient between choroidal MvV and PPA area | Correlation coefficient between choroidal MvV and parapapillary atrophy beta area | baseline | 
| Correlation coefficient between choroidal MvV and choroid thickness | Correlation coefficient between choroidal MvV and choroid thickness | baseline | 
| Correlation coefficient between choroidal MvV and RNFL thickness | Correlation coefficient between choroidal MvV and RNFL thickness | baseline | 
| Correlation coefficient between choroidal MvV and Axial length | Correlation coefficient between choroidal MvV and Axial length | baseline | 
| Correlation coefficient between choroidal MvV and retinal parapapillary perfusion | Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images. | baseline | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCTA, Myopia, Choroid