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Not yet recruiting NCT04255524

Choroidal Change on OCTA in Eyes With High Myopia

No phase Interventional Myopia, Progressive Choroid Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic coherence tomography angiography (OCTA).
Who it may be relevant to
Registry conditions: Myopia, Progressive, Choroid Disease. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia

Overview

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.

Interventions

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

Primary outcome measures

  • Parapapillary choroidal microvasculature void (MvV) area [Time frame: changes of MvV area from at 10 years]
  • Parapapillary choroidal microvasculature void (MvV) area [Time frame: difference of MvV area in each group at baseline]
  • Parapapillary choroidal microvasculature void (MvV) area [Time frame: changes of MvV area at 1 years]
  • Parapapillary choroidal microvasculature void (MvV) area [Time frame: changes of MvV area at 3 years]
  • Parapapillary choroidal microvasculature void (MvV) area [Time frame: changes of MvV area at 5 years]
Secondary outcome measures (8)
  • MvV number [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and refractive power [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and PPA area [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and choroid thickness [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and RNFL thickness [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and Axial length [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and retinal parapapillary perfusion [Time frame: baseline]
  • Correlation coefficient between choroidal MvV and Macular perfusion [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT04255524 · OCTAPPA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗