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临床试验/CTRI/2023/03/051050
CTRI/2023/03/051050尚未招募不适用

Central Macular, Ganglion cell Complex (GCC) and Peripapillary nerve fiber layer thickness (NFL) in patients with Myopia, Hyperopia and Emmetropia-A Optical Coherence Tomography Study (OCT)

DR AISHWARYA MISHRA1 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2023年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
213
试验地点
1
主要终点
Central Macular thickness, Ganglion cell complex thickness and Retinal nerve fiber layer thickness will be measured

研究概览

简要总结

Optical Coherence tomography (OCT) is noninvasive, non-contact method of cross-section imaging technology. It allows detection, assessment and measurement of various retinal diseases. It was first introduced in 1991 and by 2000s it was widely used in ophthalmology to detect diseases like glaucoma and retinal diseases.

Refractive error is associated with changes in Retinal Thickness. These changes are more extensively studied in myopic. Kang S and Hong S reported on thinning of superior and inferior RNFL in myopia and peak RNFL thickness temporally [1]. Lu B and Wang Y found GCC fiber thickest superonasally and thinnest inferiorly in young myopic Chinese adults [2]. Zhao M et al concluded that central macular thickness in myopic maximum in central foveal region and minimum in inner and outer region expect inner superior and nasal region. It was consisted with anatomy of nerve fiber, more crowded in inner region and relatively dispersed in outer region [3]. TaÅŸ M et al inferred thicker RNFL in superior and nasal quadrant of high hyperopic children [4] and no other much study has been done in adults, hence the understanding of RNFL, GCC and central macular thickness in hyperopic is limited. Lee JWY et al found that global thinning of RNFL in myopic children as compared to emmetropes and hyperopes [5]. And another study by Yau GSK and Lee JWY reported central macular thickness in myopic were significantly thicker than other emmetropic and hyperopic group of children [6]. They also agreed to postulation that this difference in macular thickness mainly due to compensatory response to thinner peripheral fibers in myopic to maintain fovea. Last two studies are only studies that compared three refractive groups with retinal thickness. But both of these studies were done in Chinese children, no similar studies have been done in adults

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Myopes (<−12.0 D), Emmetropes Hyperopes (<+5 D).

排除标准

  • •Patients not consenting for the study Ocular diseases like glaucoma, hypertensive retinopathy, diabetic retinopathy and optic neuropathy Age <18 years.

结局指标

主要结局

Central Macular thickness, Ganglion cell complex thickness and Retinal nerve fiber layer thickness will be measured

时间窗: BASELINE

次要结局

  • Comparison between Myopia, Hyperopia and Emmetropia(End of sample collection with baseline values)

研究者

发起方
DR AISHWARYA MISHRA
申办方类型
Other [self]

研究点 (1)

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