A Prospective Study to Evaluate Swept-Source OCT and Adaptive Optics Imaging of Diseases of the Vitreous, Retina and Choroid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 3 repeated measurements of choroid + retinal thickness using SD-OCT and SS-OCT and optic nerve head imaging
研究概览
简要总结
The objectives of this study include using the new technology of SS-OCT (swept source optical coherence tomography) to evaluate morphological abnormalities of the vitreous, retina and choroid and to assess the repeatability of retinal and choroidal thickness measurements in retinal disease using SS-OCT. A secondary objective is to use the new imaging modality of adaptive optics to directly visualize photoreceptor mosaics and microvasculature in eyes with retinal and choroidal disease.
详细描述
Diseases affecting the vitreous, retina and choroid are among the commonest causes of sight-loss and vision impairment in England and Wales.
These diseases may display a wide range of pathological features including vitreous, retinal and subretinal haemorrhage; macular fluid; choroidal inflammation and choroidal masses.
The retina is a 'window to the brain' and there is increasing evidence that neurodegenerative disorders such as Multiple Sclerosis, Parkinsons Disease and Alzheimers Disease have retinal manifestations which may have prognostic implications, afford earlier diagnosis, and potentially act as surrogate endpoints for treatment trials.
In 2012, a further advance in OCT technology was brought to market with the arrival of the first commercial available swept-source OCT (SS-OCT) device (the Topcon DRI OCT). SS-OCT technology uses a tuneable laser light source with a longer wavelength of light (typically 1040-1050 nm central wavelength) than the light sources seen in more conventional SD-OCT devices. This leads to greater tissue penetration with less backscatter from the RPE, producing images of the choroid with greater resolution with fast image acquisition speeds (100,000 A scans/s) and longer line scan lengths. The ability to take rapid scans with the only commercially available SS-OCT device (the DRI, Tocon Inc. Paramus, NY, USA) also enhances image quality by line scan averaging capability.
The high axial resolution of OCT allows discrimination of the distinct retinal layers that are affected differentially in different diseases. More direct visualisation of the photoreceptor layer is afforded by use of an Adaptive Optics Scanning Light Ophthalmoscope (AOSLO), which provides excellent lateral resolution and allows direct visualisation of the cone and rod photoreceptor mosaics in vivo by correcting for ocular aberrations and resulting in a lateral comparable with histopathological sections.
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
- 否
入选标准
- •Patients attending Moorfields Eye Hospital with a diagnosis of diseases of the vitreous, retina or choroid in at least one eye including but not restricted to:
- •Vitreomacular interface abnormalities including macular hole
- •Age-related macular degeneration
- •Diabetic macular oedema and retinopathy
- •Other causes of macular oedema
- •Inherited retinal dystrophies
- •Inherited macular dystrophies
- •Posterior Uveitis (infectious and non-infectious)
- •Retinal nerve fibre layer loss (eg due to glaucoma)
- •Patients with neurodegenerative diseases such as multiple sclerosis for which there is previous literature identifying retinal/choroidal abnormalities referred by Consultant Neurologists within UCL Partners
- •Male or female aged 18 years old or over.
- •Ability to understand nature/purpose of study and to provide informed consent
- •Ability to undergoing imaging
- •Ability to follow instructions and complete study
排除标准
- •History of previous significant ocular trauma
- •Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.
结局指标
主要结局
3 repeated measurements of choroid + retinal thickness using SD-OCT and SS-OCT and optic nerve head imaging
时间窗: 3 years
次要结局
- Percentage concordance and Kappa statistics of detection of morphological abnormalities in widefield OCT and conventional filed OCT (Spectralis OCT)(3 years)
- Repeated measures of photoreceptor mosaic integrity and microsvasculature (subset of patients only) at 2 visits(3 years)