Choroidal Change on OCTA in Eyes With High Myopia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia, Progressive; Choroid Disease
• Intervention / Treatment: Device: Optic coherence tomography angiography (OCTA)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinghuai Liu, PhD, MD; Phone Number: +8615195960100; Email: liuqh@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Deny to sign the patient consent, or deny to be followed
2. Evidence of cardiac, or diabetic, or CNS disease.
3. Clinically diagnosed with retinal or choroidal disease
4. Glucoma
5. Cataract or corneal disease that influence the quality of fundus OCTA image

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2030
• Study Completion (ANTICIPATED): December 31, 2030

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: OCTA; Myopia; Choroid
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Refractive Errors; Myopia; Myopia, Degenerative; Choroid Diseases
• Other Study ID Numbers: OCTAPPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After completion of the prospective observational study, we would like to share data for reasonable request from other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No