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临床试验/NCT03592017
NCT03592017已完成不适用

Performance of Optimized Long-wavelength Fundus Autofluorescence Imaging in Patients With Retinal Diseases

Oxford University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
1
主要终点
Performance of long-wavelength autofluorescence imaging

研究概览

简要总结

Fundus autofluorescence imaging has become an important diagnostic tool in ophthalmology, guiding diagnosis and assessment of progression of retinal diseases. This study investigates the performance of optimized long-wavelength autofluorescence imaging. To achieve this goal, the investigators will determine an optimal long wavelength excitation light and investigate the autofluorescence signal intensity in normals and patients with different retinal diseases. The diagnostic performance of the long-wavelength autofluorescence will be evaluated by assessing sensitivity and specificity for diagnosing a variety of degenerative retinal diseases and by comparing it to conventional autofluorescence.

详细描述

Fundus autofluorescence (AF) imaging of the retina with confocal scanning laser ophthalmoscopy has been established as a non-invasive imaging modality for the diagnosis of retinal and macular diseases. Long-wavelength near-infrared autofluorescence (excitation: 787 nm, LW-AF) is a new, innovative alternative to the classic autofluorescence imaging using 488 nm blue excitation light. Excitation of the fluorophores at the ocular fundus using a longer wavelength has several advantages. However, with the current imaging technique the autofluorescence signal and thus image quality is considerably lower compared to conventional short-wavelength autofluorescence (SW-AF). This may be the main reason for the currently limited application and scarce scientific publications on this technique.

Therefore, the objective of this study is to assess the performance of an optimized setup of long-wavelength autofluorescence imaging in clinical routine applications. For this purpose, additional laser sources will be integrated into a scanning laser ophthalmoscope and the performance with regards to image quality will be investigated systematically using different excitation wavelengths and filter combinations in healthy controls.

In a next step, the signal intensity will be quantified using an integrated fluorescent reference. First, factors affecting measurements will be identified, followed by generation of a normative database. Subjects with various retinal diseases will then be investigated and compared to the normative database.

Finally, the diagnostic performance of long-wavelength autofluorescence imaging to detect retinal degenerative diseases will be investigated and compared to conventional imaging techniques.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 years or above
  • •Defined retinal disease (patients) or no known retinal disease (healthy participants)
  • •Participants willing to read and understand the study information and provide informed consent
  • •Participants agree to have some examinations and photographs taken from their eyes

排除标准

  • •Significant opacities of the ocular media
  • •difficulties positioning still in front of the camera
  • •any ocular/ general disease known to affect recordings and/or analysis of retinal images
  • •Pupil diameter <5mm

研究组 & 干预措施

Patients with various retinal diseases

Experimental

Patients with various retinal diseases will be examined using long-wavelength autofluorescence imaging to assess the performance compared to conventional imaging methods and to quantify the signal compared to a normative database

干预措施: Long-wavelength autofluorescence imaging (Device)

Healthy participants

Experimental

Healthy participants will be examined using long-wavelength autofluorescence imaging to optimize the signal with additional laser sources and device settings and to compile a normative database for the quantification of the signal.

干预措施: Long-wavelength autofluorescence imaging (Device)

结局指标

主要结局

Performance of long-wavelength autofluorescence imaging

时间窗: 1 day

The sensitivity and specificity to detect characteristics in retinal diseases will be investigated in patients with various retinal diseases and compared to conventional imaging methods

次要结局

  • Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases(1 day)
  • Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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