LONDON, UK, 14 June 2012 - Optos plc (LSE: OPTS), a leading medical retinal imaging company, today announces the results of a clinical validation study comparing Optos ultra-widefield imaging to Early Treatment Diabetic Retinopathy Study (ETDRS) protocol fundus photography, the gold standard for assessing severity of diabetic retinopathy. The study, completed by the Joslin Diabetes Center, has been published in the American Journal of Ophthalmology.
ETDRS protocol seven standard field 30-degree color fundus photography (ETDRS photos) has long been the imaging benchmark for assessing diabetic retinopathy severity. This study reports that the Optos’ ultra-widefield non-dilated optomap images compared favorably with dilated ETDRS photos and dilated retinal examination in determining clinical severity of diabetic retinopathy and diabetic macular edema.
Researchers at Joslin’s Beetham Eye Institute, led by Lloyd Paul Aiello, MD, PhD, compared non-dilated ultra-widefield images and ETDRS photos in 103 patients with various severity levels of diabetic retinopathy. The two imaging modalities exactly matched for clinical level of diabetic retinopathy in 84% of patients and were within 1 level of agreement in 91%. Sensitivity and specificity of ultra-widefield images for detecting the presence or absence of diabetic retinopathy (DR) diagnosed on ETDRS photos were 99% and 100%.
The study also measured the length of time to capture images using both the Optos device and a traditional digital fundus camera and found that optomap imaging took less than half the time of dilated ETDRS photos not including the time needed to dilate the eyes. Thus, optomap can now allow more efficient imaging while still maintaining the current standards of diabetic retinopathy identification.
Dr Aiello said: “In this study, nonmydriatic ultra-widefield imaging compared favorably with dilated Early Treatment Diabetes Retinopathy Study protocol photography and dilated retinal examination in determining clinical severity of diabetic retinopathy and diabetic macular edema. The additional benefits of easier operation, no pupil dilation and more rapid image acquisition will be significant improvements if these results are confirmed across diverse sites and broader diabetic populations.”
Roy Davis, CEO of Optos, added: “We are extremely pleased with these results which clearly demonstrate that the ultra-widefield optomap technology compares favorably to current imaging standards in assessing diabetic retinopathy. We believe that this study, combined with the increasing body of clinical evidence, demonstrates the benefits of ultra-widefield imaging to clinicians.”
Roy Davis, CEO Christine Soden, CFO
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About Diabetic Retinopathy
Diabetic retinopathy is responsible for 4.8% of the 37 million cases of blindness due to eye diseases. Diabetic Retinopathy can be a devastating disease for sufferers. It is estimated that amongst adults it is responsible for 17% of total blindness in parts of the Americas, Europe and the Western Pacific. That figure is expected to rise with the growing obesity epidemic. The risk of losing vision as a result of Diabetic Retinopathy can be halted significantly with prompt identification and treatment of the disease with Pharmaceutical or Photocoagulation therapy. Well-conducted clinical trials have shown that good control of diabetes and hypertension significantly reduces the risk for diabetic retinopathy, and there is evidence from studies spanning more than 30 years that treatment of established retinopathy can reduce the risk for visual loss by more than 90%. Once vision has been lost due to diabetic retinopathy, it usually cannot be restored, although some forms of retinopathy can be treated by complex vitreo-retinal surgery. Screening programs for detecting diabetic retinopathy at a stage at which treatment can prevent visual loss and health education programs are the mainstay of prevention of blindness due to diabetic retinopathy. Care for diabetic retinopathy is relatively expensive and requires properly trained eye-care professionals. The decisions made by each country are adapted to their resources, social expectations and available health-care infrastructure. Effective services for prevention and treatment of diabetic retinopathy can be provided only if adequate medical services for patients with diabetes mellitus are in place.
About Optos Plc
Optos plc is Building The Retina Company. Our vision is to be recognized as a leading provider of devices to ophthalmic professionals for improved patient care. Optos' core devices produce ultra- widefield, high resolution digital images of approximately 82% of the retina, something no other device is capable of doing in any one non contact image capture. The images provide optometrists and ophthalmologists with enhanced clinical information which facilitates the early detection, management and treatment of disorders and diseases evidenced in the retina such as diabetic retinopathy, glaucoma, retinal detachments and tears and age-related macular degeneration. Retinal imaging can also indicate evidence of non-eye or systemic diseases such as hypertension and certain cancers.
Optos has a range of medical devices that support different customer segments and patient levels: the P200 and 200Dx devices are concentrated on wellness screening carried out by optometrists and ophthalmologists in primary care; the P200C device is designed to meet the need for more exacting clinical imaging capabilities and standards in secondary care within the ophthalmology market and at optometric practices that are clinically managing a patient base with advanced ocular disease; and the 200Tx device supports ophthalmologists and retinal specialists in the medical care market. Optos’ product range has been expanded to include the AccuPen, PachPen and B-Scan handheld devices for glaucoma and tumor management. Additional new products include devices for both optometrist and ophthalmologist practices, (such as the visual acuity products, perimeters and treatment lasers). In the last year, Optos has also expanded our geographic reach outside our core North American and European markets.
For more information please visit our website www.optos.com