Choroidal Change on OCTA in Eyes With High Myopia

• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04255524
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 131
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Progressive; Choroid Disease	Device: Optic coherence tomography angiography (OCTA)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia
• Anticipated Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2030
• Anticipated Study Completion Date: Dec 31, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Parapapillary choroidal microvasculature void (MvV) area [changes of MvV area from at 10 years]

   area of parapapillary choroidal microvasculature void on OCTA images

2. Parapapillary choroidal microvasculature void (MvV) area [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 [changes of MvV area at 1 years]

   area of parapapillary choroidal microvasculature void on OCTA images

4. Parapapillary choroidal microvasculature void (MvV) area [changes of MvV area at 3 years]

   area of parapapillary choroidal microvasculature void on OCTA images

5. Parapapillary choroidal microvasculature void (MvV) area [changes of MvV area at 5 years]

   area of parapapillary choroidal microvasculature void on OCTA images

Secondary Outcome Measures

1. MvV number [baseline]

   number of choroidal MvV with certain size

2. Correlation coefficient between choroidal MvV and refractive power [baseline]

   Correlation coefficient between choroidal MvV and refractive power

3. Correlation coefficient between choroidal MvV and PPA area [baseline]

   Correlation coefficient between choroidal MvV and parapapillary atrophy beta area

4. Correlation coefficient between choroidal MvV and choroid thickness [baseline]

   Correlation coefficient between choroidal MvV and choroid thickness

5. Correlation coefficient between choroidal MvV and RNFL thickness [baseline]

   Correlation coefficient between choroidal MvV and RNFL thickness

6. Correlation coefficient between choroidal MvV and Axial length [baseline]

   Correlation coefficient between choroidal MvV and Axial length

7. Correlation coefficient between choroidal MvV and retinal parapapillary perfusion [baseline]

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

8. Correlation coefficient between choroidal MvV and Macular perfusion [baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

• The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04255524
• Other Study ID Numbers: OCTAPPA
• First Posted: Feb 5, 2020
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Affiliated Hospital with Nanjing Medical University: OCTA; Myopia; Choroid
• Additional relevant MeSH terms: Myopia; Myopia, Degenerative; Choroid Diseases

Study Results

No Results Posted as of Feb 5, 2020