MedPath

Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With OCTA

Completed
Conditions
Myopia
Interventions
Diagnostic Test: Comprehensive ophthalmologic examination
Registration Number
NCT04631991
Lead Sponsor
Akdeniz University
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.

Detailed Description

Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination, including measurements of best-corrected visual acuity, refractive error; intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination and OCTA imaging are included. The best-corrected visual acuity is convert into the logarithm of minimal angle resolution. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented 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.

Right eye of each participant is included in the study. If the right eye shows any exclusion criteria, then the left eye is selected for enrollment. Eyes with an AL longer than 26 mm are included in the HM group. The classification of myopic maculopathy is applied in identification of fundus alterations. Patients with category 0 (no myopic retinopathy lesions) and category 1 (tessellated fundus) are included in the study.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria
  • Patients with category 0 (no myopic retinopathy lesions)
  • Patients with category 1 (tessellated fundus)
Exclusion Criteria
  • 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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Non-pathological high myopiaComprehensive ophthalmologic examinationComprehensive ophthalmologic examination
ControlComprehensive ophthalmologic examinationComprehensive ophthalmologic examination
Primary Outcome Measures
NameTimeMethod
Optic nerve head vessel density10 minutes

Optic nerve head vessel density assessed with optical coherence tomography angiography

Secondary Outcome Measures
NameTimeMethod
Choriocapillaris flow area10 minutes

Choriocapillaris flow area assessed with optical coherence tomography angiography

Subfoveal central macular thickness10 minutes

Subfoveal central macular thickness assessed with optical coherence tomography angiography

Subfoveal choroidal thickness10 minutes

Subfoveal choroidal thickness assessed with optical coherence tomography angiography

Foveal avascular zone10 minutes

Foveal avascular zone assessed with optical coherence tomography angiography

Trial Locations

Locations (1)

Aslı Çentinkaya Yaprak

🇹🇷

Antalya, Turkey

© Copyright 2025. All Rights Reserved by MedPath