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临床试验/NCT04631991
NCT04631991已完成不适用

Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With Optical Coherence Tomography Angiography

Akdeniz University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Optic nerve head vessel density

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with category 0 (no myopic retinopathy lesions)
  • Patients with category 1 (tessellated fundus)

排除标准

  • 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.

结局指标

主要结局

Optic nerve head vessel density

时间窗: 10 minutes

Optic nerve head vessel density assessed with optical coherence tomography angiography

次要结局

  • Choriocapillaris flow area(10 minutes)
  • Subfoveal central macular thickness(10 minutes)
  • Subfoveal choroidal thickness(10 minutes)
  • Foveal avascular zone(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aslı Çetinkaya Yaprak

Principal Investigator

Akdeniz University

研究点 (1)

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