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NCT Number: NCT04255524

Choroidal Change on OCTA in Eyes With High Myopia

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.

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Key information

Conditions

Myopia, Progressive Choroid Disease Choroid Diseases Eye Diseases Myopia Myopia, Degenerative Refractive Errors Uveal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optic coherence tomography angiography (OCTA)

Device

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

Primary outcomes

  1. Parapapillary choroidal microvasculature void (MvV) area

    Time frame: changes of MvV area from at 10 years

    area of parapapillary choroidal microvasculature void on OCTA images

  2. Parapapillary choroidal microvasculature void (MvV) area

    Time frame: difference of MvV area in each group at baseline

    area of parapapillary choroidal microvasculature void on OCTA images

  3. Parapapillary choroidal microvasculature void (MvV) area

    Time frame: changes of MvV area at 1 years

    area of parapapillary choroidal microvasculature void on OCTA images

  4. Parapapillary choroidal microvasculature void (MvV) area

    Time frame: changes of MvV area at 3 years

    area of parapapillary choroidal microvasculature void on OCTA images

  5. Parapapillary choroidal microvasculature void (MvV) area

    Time frame: changes of MvV area at 5 years

    area of parapapillary choroidal microvasculature void on OCTA images

Secondary outcomes

  1. MvV number

    Time frame: baseline

    number of choroidal MvV with certain size

  2. Correlation coefficient between choroidal MvV and refractive power

    Time frame: baseline

    Correlation coefficient between choroidal MvV and refractive power

  3. Correlation coefficient between choroidal MvV and PPA area

    Time frame: baseline

    Correlation coefficient between choroidal MvV and parapapillary atrophy beta area

  4. Correlation coefficient between choroidal MvV and choroid thickness

    Time frame: baseline

    Correlation coefficient between choroidal MvV and choroid thickness

  5. Correlation coefficient between choroidal MvV and RNFL thickness

    Time frame: baseline

    Correlation coefficient between choroidal MvV and RNFL thickness

  6. Correlation coefficient between choroidal MvV and Axial length

    Time frame: baseline

    Correlation coefficient between choroidal MvV and Axial length

  7. Correlation coefficient between choroidal MvV and retinal parapapillary perfusion

    Time frame: baseline

    Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images.

  8. Correlation coefficient between choroidal MvV and Macular perfusion

    Time frame: baseline

    Correlation coefficient between choroidal MvV and Macular perfusion on OCTA images, Retinal parapapillary perfusion with OCTA.

Study contacts

Contact information is provided by the study sponsor or research team.

Qinghuai Liu, PhD, MD

CONTACT

[email protected]

+8615195960100

Zizong Hu, PhD, MD

CONTACT

[email protected]

+8615195960100

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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