Investigation of Retinal Pathology in Eye Diseases Using High Resolution Optical Coherence Tomography (High-Res-OCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid
研究概览
简要总结
Comparison of high-resolution optical coherence tomography (High-Res-OCT) to conventional imaging modalities for the diagnosis of eye diseases
详细描述
The high resolution optical coherence tomography (High-Res-OCT) is an improvement of a non-invasive routinely used imaging technique, the optical coherence tomography (OCT), with a light-source capable of providing an increased axial resolution. The routinely used Spectral-Domain OCT has a center wavelength of 880 nm and a spectral bandwidth of 40 nm, resulting in an axial resolution of approximately 7 μm in the eye and is used routinely worldwide. The High-Res OCT works with a central wavelength of 840 nm and an increased bandwidth of 130 nm, making it possible to improve the optical axial resolution in tissue from 7 to 3 µm, without increasing the maximum laser exposure limit. The improved axial resolution of the High-Res OCT results in clearer and more detailed images. The technique is routinely used in clinical practice and the device used for High-Res-OCT (Heidelberg, SPECTRALIS® High-Res OCT- DMR001) has received CE mark (european conformity in the extended Single Market in the European Economic Area) approval in March 2021. We plan to compare High-Res-OCT as an imaging modality to conventional imaging modalities used in clinical routine, such as the Spectral-Domain-OCT (SD-OCT)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older
排除标准
- •Patients not willing or able to sign informed consent
- •Patients younger than 18 years
- •Patients with epilepsy.
- •Vulnerable subjects (except the objectives of the investigation concern vulnerable subjects specifically),
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- •Enrolment of the PI, his/her family members, employees and other dependent persons
结局指标
主要结局
Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid
时间窗: 2 years
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose retinal morphological abnormalities with High-Resolution OCT compared to conventional imaging method (SD-OCT). The main parameter that will be assessed is the presence/absence of retinal fluid. The incidence (binary) of retinal fluid will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT)
次要结局
- Evaluation of the sensitivity and specificity of High-Res-OCT for atrophy area(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for optic disc swelling(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for drusen(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for scars(2 years)
- Evaluation of the inter-reader reproducibility(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for hyperreflective foci(2 years)
- Subgroup analysis(2 years)
- Evaluation of the segmentation quality of the retinal layers using High-Res-OCT(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for epiretinal membrane(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for ischemia(2 years)
- Evaluation of the sensitivity and specificity of High-Res-OCT for neovascularisation(2 years)