NCT04255524

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Feb 2020Dec 2030

First Submitted

Initial submission to the registry

January 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

10.9 years

First QC Date

January 31, 2020

Last Update Submit

February 2, 2020

Conditions

Myopia, ProgressiveChoroid Disease

Keywords

OCTAMyopiaChoroid

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (8)

  • MvV number

    baseline

  • Correlation coefficient between choroidal MvV and refractive power

    baseline

  • Correlation coefficient between choroidal MvV and PPA area

    baseline

  • Correlation coefficient between choroidal MvV and choroid thickness

    baseline

  • Correlation coefficient between choroidal MvV and RNFL thickness

    baseline

  • +3 more secondary outcomes

Study Arms (4)

Group 1/Control

EXPERIMENTAL

Spherical equivalent: -2.00～+2.00 D

Device: Optic coherence tomography angiography (OCTA)

Group 1/Myopia

EXPERIMENTAL

Spherical equivalent: -3.00～-6.00 D

Device: Optic coherence tomography angiography (OCTA)

Group 3/High

EXPERIMENTAL

Spherical equivalent: -6.00～-10.00 D

Device: Optic coherence tomography angiography (OCTA)

Group 4/Super High

EXPERIMENTAL

Spherical equivalent: \<-10.00

Device: Optic coherence tomography angiography (OCTA)

Interventions

Optic coherence tomography angiography (OCTA)DEVICE

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

Group 1/ControlGroup 1/MyopiaGroup 3/HighGroup 4/Super High

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Myopia, DegenerativeChoroid DiseasesMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesUveal Diseases

Central Study Contacts

Zizong Hu, PhD, MD

CONTACT

+8615195960100huzizhong@njum.edu.cn

Qinghuai Liu, PhD, MD

CONTACT

+8615195960100liuqh@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

After completion of the prospective observational study, we would like to share data for reasonable request from other researchers.

Locations

CN(1)