A new test can detect glaucoma progression 18 months earlier than the current gold standard method. The technology, supported by an artificial intelligence (AI) algorithm, 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."
Glaucoma, the leading cause of irreversible blindness worldwide, affects over 60 million people. Vision lost to glaucoma is caused by the death of cells in the retina, at the back of the eye, a process called apoptosis.
The test, called DARC (Detection of Apoptosing Retinal Cells), involves injecting a fluorescent dye into the bloodstream (via the arm) that attaches to retinal cells, and illuminates those that are in the process of apoptosis. The damaged cells appear bright white when viewed in eye examinations.
One challenge with evaluating eye diseases is that specialists often disagree when viewing the same scans, so the researchers have incorporated an AI algorithm into their method.
In the Phase II clinical trial of DARC, AI was used to assess 60 patients, 20 with glaucoma and 40 healthy control subjects. The AI was initially trained on retinal scans of healthy subjects following the injection of the dye, and then tested on 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. "These results are very promising as they show DARC could be used as a biomarker when combined with the AI-aided algorithm," said Professor Cordeiro.
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.”
The AI-supported technology has recently been approved by both the UK's Medicines and Healthcare products Regulatory Agency and the USA's Food and Drug Administration as an exploratory endpoint for testing a new glaucoma drug in a clinical trial.