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临床试验/NCT04424069
NCT04424069Unknown不适用

Optical Coherence Tomography Angiography Analysis of Macular and Papillary Perfusion After Variable Refractive Surgery Methods in Myopic Patients

Tanta University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Vessel density from enface OCT angiogram

研究概览

简要总结

Refractive surgery for correction of myopia is very common nowadays. However, various refractive techniques may be associated with increase in the IOP, especially during flap creation. It is assumed that marked intraoperative IOP increase lead to macular and optic disc head circulation compromise. The purpose of this study is to assess the change of macular and papillary perfusion, using optical coherence tomography angiography (OCTA) imaging of the macula and optic disc of myopic patients before and after various refractive surgery methods.

详细描述

Myopia is the most prevalent ocular disorder in children worldwide, and one of the major causes of visual deterioration in all age groups. Highest prevalence rates are in East Asian countries (affecting up to 83% of Singaporean teenagers), however, it is very common in all other countries. While mild to moderate myopia usually stabilizes within the third decade, pathological myopia is associated with progressive globe elongation, and development of various macular complications including; foveoschisis, choroidal neovascularization (CNV), myopic macular hole, and myopic vitreomacular traction (VMT).

Refractive surgery has become popular for correcting ametropia including myopia. Most commonly used refractive procedures include corneal refractive surgeries especially laser in-situ keratomileusis (LASIK), and Photorefractive keratectomy (PRK), Phakic Intraocular Lenses (Phakic IOLs) and refractive lens exchange.

In LASIK, the creation of a corneal lamellar flap requires placement of a suction ring on the anterior segment of the eye, which transiently elevates the intraocular pressure (IOP) to levels exceeding 65 mmHg. Experimental studies in animal eyes have found that the IOP can increase to between 80 mmHg and 360 mmHg during this vacuum phase and lamellar cut with the microkeratome. Recent advances utilizing the femtosecond laser may serve as an alternative to the mechanical microkeratome, with a low-pressure suction ring. In studies using porcine eyes, the IOP during the suctioning or laser application phase reached a maximum of 135 mmHg using the femtosecond laser, lower than pressures reached with a traditional microkeratome, but for a longer duration of time. Similarly in refractive lens procedures, intraoperative IOP was found to exceed 60 mmHg.

Intraocular pressure elevation during refractive procedures may cause a reduction in the perfusion of the retina and optic nerve head, posterior displacement of the lamina cribrosa, and a decline in ocular perfusion pressure of the posterior ciliary arteries. Although this IOP elevation is temporary, the potential for ischemic or pressure-induced damage to the optic nerve head and the retinal nerve fiber layer exists.

Optical coherence tomography angiography (OCTA) is a recent noninvasive imaging technique that allows for volumetric visualization of eye vasculature. OCTA has shown promise in better elucidating the pathophysiology of several retinal vascular diseases. Swept-source OCTA uses long wavelength ̰ 1,050nm, which can penetrate through deeper layers of the eye and can traverse opacities of media such as cataracts, hemorrhages and vitreous opacities [6]. Optical coherence tomographic angiograms can further be manually or automatically segmented with preprogrammed software to highlight individual layers of the retina, optic nerve head choriocapillaris, and choroid. The user can either analyze en face images extending from the inner limiting membrane to choroid or use automated views to locate a vascular or structural lesion within the retina.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: between 20 - 35 years
  • Patients: who are seeking and fit for refractive surgery
  • Spherical equivalent refractive error: between (-2 to -9 D)

排除标准

  • Maculopathies (hereditary or acquired)
  • optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.)
  • optic neuropathies (demyelinating, infectious, ischemic, etc.)
  • adjusted IOP for central corneal thickness more than 21 mmHg
  • surgery-induced corneal edema
  • dense cataracts that can disrupt images
  • systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.)
  • any previous ocular surgery,
  • patients with bad quality images or complicated surgeries will be excluded

结局指标

主要结局

Vessel density from enface OCT angiogram

时间窗: 6 months

VD analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area

次要结局

未报告次要终点

研究者

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

Osama Abdelfattah Sorour

Retina consultant & the principal investigator

Tanta University

研究点 (2)

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