Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With OCTA
1 other identifier
observational
70
1 country
1
Brief Summary
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination are included. The Optical Coherence Tomography Angiography (OCTA) software automatically segments these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2020
CompletedFirst Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
November 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2020
CompletedJanuary 14, 2021
January 1, 2021
25 days
November 11, 2020
January 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Optic nerve head vessel density
Optic nerve head vessel density assessed with optical coherence tomography angiography
10 minutes
Secondary Outcomes (4)
Choriocapillaris flow area
10 minutes
Subfoveal choroidal thickness
10 minutes
Foveal avascular zone
10 minutes
Subfoveal central macular thickness
10 minutes
Study Arms (2)
Non-pathological high myopia
Comprehensive ophthalmologic examination
Control
Comprehensive ophthalmologic examination
Interventions
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.
Eligibility Criteria
Study population includes a convenience sampling from the patients admitted to outpatient clinic between November 2020 and December 2020.
You may qualify if:
- Patients with category 0 (no myopic retinopathy lesions)
- Patients with category 1 (tessellated fundus)
You may not qualify if:
- poor image quality (signal strength index (SSI) \<60) due to unstable fixation
- IOP \>21 mm Hg; logMAR \> 0.1
- pre-existing ophthalmic pathologies
- prior ocular surgery
- systemic chronic disease which can cause retinopathy
- such as diabetes mellitus, hypertension etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aslı Çentinkaya Yaprak
Antalya, 070059, Turkey (Türkiye)
Related Publications (1)
Yaprak AC, Yaprak L. Retinal microvasculature and optic disc alterations in non-pathological high myopia with optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3221-3227. doi: 10.1007/s00417-021-05216-x. Epub 2021 May 7.
PMID: 33961111DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 11, 2020
First Posted
November 17, 2020
Study Start
November 10, 2020
Primary Completion
December 5, 2020
Study Completion
December 8, 2020
Last Updated
January 14, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share