Clinical trial NCT04631991: Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With OCTA
Official title: Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes a convenience sampling from the patients admitted to outpatient clinic between November 2020 and December 2020.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Optic nerve head vessel density
timeFrame: 10 minutes
Secondary outcomes:
measure: Choriocapillaris flow area
timeFrame: 10 minutes
measure: Subfoveal choroidal thickness
timeFrame: 10 minutes
measure: Foveal avascular zone
timeFrame: 10 minutes
measure: Subfoveal central macular thickness
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Aslı Çentinkaya Yaprak
Study officials:
References:
citation: 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.