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Myopia, ProgressiveNCT04255524

Choroidal Change on OCTA in Eyes With High Myopia

A study testing Optic coherence tomography angiography (OCTA) in people with Myopia, Progressive and Choroid Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Myopia, Progressive, Choroid Disease
What is being tested?
Optic coherence tomography angiography (OCTA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Feb 2020to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Spherical equivalent measurement can be included in above 4 groups
  • Willing to be followed up in the future 10 years

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zizong Hu, PhD, MD contact

+8615195960100

huzizhong@njum.edu.cn

Qinghuai Liu, PhD, MD contact

+8615195960100

liuqh@njmu.edu.cn

China1 site

  • First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in 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.

Being tested
Optic coherence tomography angiography (OCTA)
Keywords
OCTA, Myopia, Choroid
Medical subject headings
Myopia, Degenerative, Choroid Diseases, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optic coherence tomography angiography (OCTA)Device

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

Study groups in NCT04255524
Study groupRoleWhat they receive
Group 1/ControlExperimentalSpherical equivalent: -2.00～+2.00 D
Receives: Device: Optic coherence tomography angiography (OCTA)
Group 1/MyopiaExperimentalSpherical equivalent: -3.00～-6.00 D
Receives: Device: Optic coherence tomography angiography (OCTA)
Group 3/HighExperimentalSpherical equivalent: -6.00～-10.00 D
Receives: Device: Optic coherence tomography angiography (OCTA)
Group 4/Super HighExperimentalSpherical equivalent: <-10.00
Receives: Device: Optic coherence tomography angiography (OCTA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parapapillary choroidal microvasculature void (MvV) area

    area of parapapillary choroidal microvasculature void on OCTA images

    Measured: changes of MvV area from at 10 years

  2. Parapapillary choroidal microvasculature void (MvV) area

    area of parapapillary choroidal microvasculature void on OCTA images

    Measured: difference of MvV area in each group at baseline

  3. Parapapillary choroidal microvasculature void (MvV) area

    area of parapapillary choroidal microvasculature void on OCTA images

    Measured: changes of MvV area at 1 years

  4. Parapapillary choroidal microvasculature void (MvV) area

    area of parapapillary choroidal microvasculature void on OCTA images

    Measured: changes of MvV area at 3 years

  5. Parapapillary choroidal microvasculature void (MvV) area

    area of parapapillary choroidal microvasculature void on OCTA images

    Measured: changes of MvV area at 5 years

Secondary outcomes (8)

  1. MvV number

    number of choroidal MvV with certain size

    Measured: baseline

  2. Correlation coefficient between choroidal MvV and refractive power

    Correlation coefficient between choroidal MvV and refractive power

    Measured: baseline

  3. Correlation coefficient between choroidal MvV and PPA area

    Correlation coefficient between choroidal MvV and parapapillary atrophy beta area

    Measured: baseline

  4. Correlation coefficient between choroidal MvV and choroid thickness

    Correlation coefficient between choroidal MvV and choroid thickness

    Measured: baseline

  5. Correlation coefficient between choroidal MvV and RNFL thickness

    Correlation coefficient between choroidal MvV and RNFL thickness

    Measured: baseline

  6. Correlation coefficient between choroidal MvV and Axial length

    Correlation coefficient between choroidal MvV and Axial length

    Measured: baseline

  7. Correlation coefficient between choroidal MvV and retinal parapapillary perfusion

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

    Measured: baseline

  8. Correlation coefficient between choroidal MvV and Macular perfusion

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start1 Feb 2020 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04255524
Sponsor's protocol ID
OCTAPPA
Status last verified
Jan 2020
First submitted
31 Jan 2020
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After completion of the prospective observational study, we would like to share data for reasonable request from other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Optic coherence tomography angiography (OCTA) in people with Myopia, Progressive and Choroid Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zizong Hu, PhD, MD (+8615195960100, huzizhong@njum.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parapapillary choroidal microvasculature void (MvV) area (time frame: changes of MvV area from at 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04255524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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