跳至主要内容
临床试验/NCT04620876
NCT04620876招募中不适用

Bimodal and Coaxial High Resolution Ophtalmic Imaging

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
2
主要终点
Visualization and image analysis of a structure of interest

研究概览

简要总结

The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques.

The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers.

Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients.

The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.

详细描述

The goal of the project is the capture and analysis of images with AOSLO system, in order to evaluate the performance of this system compared to OCT imaging devices and existing Adaptive Optics used at National Hospital of Ophthalmology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • People over 18
  • Patient with a pathology affecting the eye or healthy volunteer
  • Participant who signed the consent
  • Beneficiaries of the health insurance

排除标准

  • Patients with a history of photosensitivity.
  • Patients who have just received a photodynamic therapy treatment
  • Patients taking drugs with photosensitivity as a side effect.
  • Persons with pacemakers or other implanted electronic medical device
  • Patients with viral conjunctivitis or any other infectious disease.
  • Patients with skin lesions on the neck or forehead
  • Patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease.
  • Participant unable to be followed throughout the study
  • Advanced cataract or severe opacities in the anterior segment of the eye.

结局指标

主要结局

Visualization and image analysis of a structure of interest

时间窗: From date of inclusion until the date of last documented progression , assessed up to 5 years

The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
申办方类型
Other
责任方
Sponsor

研究点 (2)

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