Glaucoma, the leading global cause of irreversible blindness, currently affects over 60 million people, which is predicted to double by 2040 as the global population ages. The new test, which is combined with Artificial Intelligence (AI) technology could help accelerate clinical trials, and eventually may be used in detection and diagnostics.
Lead researcher Professor Francesca Cordeiro, UCL Institute of Ophthalmology, Imperial College London, and Western Eye Hospital Imperial College Healthcare NHS Trust, said: We have developed a quick, automated and highly sensitive way to identify which people with glaucoma are at risk of rapid progression to blindness.
The clinical trial has been sponsored by UCL, funded by Wellcome and published in the Expert Review of Molecular Diagnostics.
The test, called DARC (Detection of Apoptosing Retinal Cells), involves injecting a fluorescent dye into the bloodstream that attaches to retinal cells and illuminates the cells that are in the process of apoptosis, a form of programmed cell death.
Currently, a major challenge with detecting eye diseases is that specialists often disagree when viewing the same scans, so the researchers have incorporated an AI algorithm into their method.
The AI was initially trained by analysing the retinal scans of the healthy control subjects. The AI was then tested on the glaucoma patients. Those taking part in the AI study were followed up 18 months after the main trial period to see whether their eye health had deteriorated.
The researchers were able to accurately predict progressive glaucomatous damage 18 months before that seen with the current gold standard OCT retinal imaging technology, as every patient with a DARC count over a certain threshold was found to have progressive glaucoma at follow-up.
Professor Francesca Cordeiro said that adding biomarkers are urgently needed for glaucoma, to speed up clinical trials as the disease progresses slowly so it can take years for symptoms to change: These results are very promising as they show DARC could be used as a biomarker when combined with the AI-aided algorithm.
What is really exciting, and actually unusual when looking at biological markers, is that there was a clear DARC count threshold above which all glaucoma eyes went on to progress.
The team is also applying the test to rapidly detect cell damage caused by a number of other conditions such as neurodegenerative conditions that involve the loss of nerve cells, including age-related macular degeneration, multiple sclerosis, and dementia, as well as testing people with lung disease. The team hope that by the end of this year the test may help to assess people with breathing difficulties from COVID-19.
First author of the study Dr Eduardo Normando, Imperial College London and Western Eye Hospital Imperial College Healthcare NHS Trust, said: Being able to diagnose glaucoma at an earlier stage, and predict its course of progression, could help people to maintain their sight, as treatment is most successful if provided at an early stage of the disease.
After further research in longitudinal studies, we hope that our test could have widespread clinical applications for glaucoma and other conditions.
The AI-supported technology has recently been approved by both the UKs Medicines and Healthcare products Regulatory Agency and the USAs Food and Drug Administration as an exploratory endpoint for testing a new glaucoma drug in a clinical trial.
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Discover how AI can help with early detection of glaucoma - Health Europa
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