Optos plc
HIGHLIGHTS
- Prospective 4 year study shows significance of peripheral lesions in predicting 3 to nearly 5-fold increased risk of diabetic retinopathy progression and development of proliferative diabetic retinopathy, respectively.
- Study identifies a population of patients with retinal lesions predominantly outside the area imaged by standard retinal fundus photography that are at a substantially higher risk of diabetic retinopathy progression than might be suggested by findings on standard retinal photography alone.
- The presence of predominantly peripheral diabetic lesions substantially increases the risks of diabetic retinopathy progression and the onset of proliferative diabetic retinopathy, demonstrating the importance of rigorous evaluation of the peripheral retina to more accurately evaluate diabetic retinopathy severity and determine progression risk.
- The presence and severity of diabetic retinopathy lesions predominantly located in the periphery are not currently evaluated in standard Early Treatment Diabetic Retinopathy Severity (ETDRS) severity grading that has been used in many clinical and research settings. These results are currently under investigation in a multicentre study sponsored by the Diabetic Retinopathy Clinical Research Network to confirm the findings and see if changes to the current ETDRS grading scales are needed to best optimise the determination of diabetic retinopathy progression risk.
- The presence of predominantly peripheral lesions was associated with the progression of diabetic retinopathy over 4 years, independent of baseline retinopathy severity and haemoglobin A1C.
Optos, a wholly owned subsidiary of Nikon Corporation, Japan and world leader in retinal imaging, announced the publication of a study in the May 2015 issue of the journal Ophthalmology. The study was conducted by Dr. Paolo Silva (Staff Ophthalmologist and Assistant Chief of Telemedicine at Joslin’s Beetham Eye Institute; and Assistant Professor of Ophthalmology at Harvard Medical School) and Dr. Lloyd Paul Aiello, (Director of Joslin’s Beetham Eye Institute and Professor of Ophthalmology at Harvard Medical School).
The primary objective of the study was to investigate whether peripheral diabetic retinal lesions predicted an increased risk of diabetic retinopathy progression and onset of proliferative diabetic eye disease. Data from this study suggest that the rigorous evaluation of the peripheral retina may help more accurately assess risk of diabetic retinopathy severity progression.
The 4 year clinical study of 100 patients was conducted independently by researchers at Joslin Diabetes Center, the Boston-based nonprofit institution providing premier diabetes care and innovative research for diabetes and its complications. The research found that eyes with diabetic lesions that were predominantly located in the peripheral retina had a 4.7-fold increased risk of progression to proliferative diabetic retinopathy and a 3.2-fold increased risk of 2 or more step progression in diabetic retinopathy severity. The results were statistically significant and were independent of baseline retinopathy severity and prior haemoglobin A1C.
In a previous study by the same researchers, the use of stereoscopic optomap images evaluated in a rigorous and standardized manner had excellent agreement with current gold standard method of diabetic retinopathy assessment, stereoscopic ETDRS 7 field standard field 35-mm colour 30-degree fundus photographs. Previously published analyses have reported that these lesions may suggest a more severe level of diabetic retinopathy in ~10% of eyes. The initial observation was confirmed in subsequent analysis of images from 1,516 eyes obtained in an established diabetic retinopathy telemedicine program where a more severe diabetic retinopathy level was suggested in 9% of eyes based on peripheral lesions identified using optomap imaging. This newest study demonstrates that evaluating diabetic retinopathy with ultra-widefield imaging can provide important diabetic retinopathy disease information using a non-mydriatic, fast and effective 200 degree retinal imaging platform.
Researchers believe that this is the first comprehensive study to quantitate the increased risk associated with the presence of predominantly peripheral diabetic retinopathy lesions visualised on ultra-widefield imaging. Dr. Aiello said “These data re-affirm the importance of evaluating the entire retina when managing diabetic retinopathy and demonstrate the increased risk of retinopathy progression that could be missed if the peripheral retina is not carefully examined. If currently on-going large multicentre trials confirm these results, then the status of the peripheral retina may need to be included in diabetic retinopathy grading scales to optimally define the risks of retinopathy progression in an individual.”
Roy Davis, CEO of Optos, said “We are pleased with the exciting results from this study. Optos has long believed that an image of the retina including the far periphery enables an eye care professional to see more pathology easier and to develop more effective treatment plans for maintaining their patients’ vision. An optomap is the most complete single image of the retina currently available and this study demonstrates its use as an integral part of a detailed peripheral retinal evaluation. For these reasons, Optos continues to invest in research and development as well as clinical studies that support optomap as an important component of the standard of care for triage and treatment decisions in retinal vascular diseases.”
Disclosures: Optos did not fund the study referenced in this press release. Optos has funded other Beetham Eye Institute research. The study publication contains a full financial disclosure. Joslin does not endorse any products.