Clinical Trial: Advanced OCT and Adaptive Optics Imaging in Retinal Disease (The ACAD Study)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Prospective Study to Evaluate Swept-Source OCT and Adaptive Optics Imaging of Diseases of the Vitreous, Retina and Choroid
Brief Summary: 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.
Detailed Summary:
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 allo
Sponsor: Moorfields Eye Hospital NHS Foundation Trust
Current Primary Outcome: 3 repeated measurements of choroid + retinal thickness using SD-OCT and SS-OCT and optic nerve head imaging [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage concordance and Kappa statistics of detection of morphological abnormalities in widefield OCT and conventional filed OCT (Spectralis OCT) [ Time Frame: 3 years ]
- Repeated measures of photoreceptor mosaic integrity and microsvasculature (subset of patients only) at 2 visits [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Moorfields Eye Hospital NHS Foundation Trust
Dates:
Date Received: July 6, 2016
Date Started: July 2015
Date Completion: May 2018
Last Updated: November 18, 2016
Last Verified: July 2016
