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临床试验/NCT03287648
NCT03287648Unknown不适用

Simultaneous Spectral-domain Optical Coherence Tomography and Blue-fundus Autofluorescence in Eyes With Alteration of the Foveal Contour

University of Molise1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Relationship between OCT and B-FAF findings

研究概览

简要总结

Some alterations of the foveal contour do not meet the criteria established for the definition of lamellar macular hole on the basis of optical coherence tomography (OCT). However, these alterations may show an appearance, on blue fundus autofluorescence (B-FAF) imaging, reminiscent of lamellar macular hole.

The aim of the study is to evaluate in detail these alterations recording simultaneously OCT and B-FAF.

详细描述

All images will be collected using the Heidelberg Spectralis system (Heidelberg Engineering, Heidelberg, Germany) according to the prespecified imaging protocols. Blue-fundus autofluorescence (excitation wavelength at 488 nm and barrier filter at 500 nm) images and SD-OCT images will be obtained after pupil dilation.

The OCT recording protocol will consist of a sequence of 37 horizontal sections, spaced 120-µm apart, covering an area of 20° or 30° horizontally by 15° vertically, and a sequence of 24 radial sections recorded in the high-resolution (HR) mode simultaneously with infrared (IR) images.

In addition, simultaneous B-FAF/OCT images will be acquired (horizontal, and vertical OCT sections, centered on the fovea and recorded in the HR mode).

The same OCT/FAF protocol will be used for the study eye and for the fellow eye.

For the study eyes that had been examined in the past, the ''Follow-up'' function will be used in addition to the prespecified protocol to evaluate if any changes had occurred since the last scan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
  • focal, well-defined increased autofluorescence signal at the fovea

排除标准

  • intraretinal cysts not associated with break of the inner retina
  • juxtafoveal telangiectasia
  • ring of increased B-FAF
  • vitelliform and pseudovitelliform lesions
  • history of diabetes, retinal vein occlusion, uveitis, CSR, AMD or any other retinal -disease potentially associated with intra or subretinal fluid
  • macular drusen
  • history of submacular hemorrhage

结局指标

主要结局

Relationship between OCT and B-FAF findings

时间窗: 6 months

Measurements of the diameters of the holes expressed in microns, on OCT and B-FAF images respectively, will be collected. The topographic correlation between the area of increased B-FAF signal and the corresponding area on OCT, will be examined.

次要结局

  • Relationship between OCT and B-FAF characteristics and logMAR visual acuity(6 months)

研究者

发起方
University of Molise
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto dell'Omo

Associate Professor

University of Molise

研究点 (1)

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