New Study Confirms the Equivalence of optomap to ETDRS Gold Standard for Grading Diabetic Retinopathy

November is Diabetes Awareness Month.  In 2015, 30.3 million Americans, or 9.4% of the population, had diabetes and approximately 1.25 million American children and adults had type 1 diabetes. These numbers are on the rise and the disease manifests with deleterious and deadly impact throughout the body – including the eye. An understanding of the disease, early detection and treatment are more imperative than ever.

 

A recent study cooperatively funded by the National Eye Institute, the National Institute of Diabetes and Digestive and Kidney diseases and the US Department of Health and Human Services concluded  that optomap ultra-widefield (UWF™) retinal imaging is a useful diagnostic tool for detection and assessment of severity of diabetic retinopathy (DR). The study published recently in JAMA Ophthalmology demonstrates that optomap UWF imaging can be used reliably in place of Early Treatment Diabetic Retinopathy Study (ETDRS) 7-Field imaging in clinical use and future clinical trials.  The paper, which builds off recent single site studies that found moderate to perfect agreement between the modalities, supports these findings through data acquired over a two-year period from multiple sites.

The gold standard assessment of DR severity has been based on grading of lesions within the ETDRS 7 standard fields. These 7 fields are time consuming in their acquisition, require dilation and once compiled represent only 34% of the retinal surface.  Advances in retinal imaging technology now allow UWF imaging to capture 82% of the retina in a single image and in less than ½ second without the need for dilation. This collaborative study offers that given the technological advances now enabling UWF imaging, and the potential benefits of this approach, there may be substantial impetus for moving to UWF imaging if it is compatible in determining DR severity, and if pathology in the retinal periphery provides additional clinically useful information on prospective worsening of retinopathy.

In this current multi-site study, there were 737 gradable eyes on both ETDRS 7-field images and UWF images masked to contain the same 7 fields after adjudication; 59% had exact agreement, and 96% were within 1 step of agreement.  The conclusion of the study clearly supported moderate to perfect agreement between modalities within the limited masked scope of the current gold standard.  As seen was seen in previous studies, when the area outside of ETDRS was assessed predominantly peripheral DR lesions (PPL) were present in 41.0% of these eyes and suggested increased DR severity  by 2 or more steps in 11.0%.

Cursorily referenced in this preliminary paper was a consideration of efficiency between modalities.  This initial study release notes that the use of UWF imaging in clinical settings not only increases the frequency of DR identification nearly 2-fold but also reduces acquisition time by more than half, ungradable image rate by 71% and image evaluation by 28% compared with non-mydriatic fundus photography.

The study suggests the possibility of UWF imaging becoming a preferred method of assessment of DR severity, not only because of moderate to perfect agreement between modalities within the ETDRS scope, but also because of the information found in UWF outside the ETDRS mask. This raises the question regarding the potential for detecting DR change and severity earlier.  Data collected from a previous study, suggests that lesions observed outside of the area captured within ETDRS may identify a possible subset of patients with the disease that may be more aggressive.  These lesions were found to suggest a 4.7 times greater risk of worsening to treatable DR over a period of four years.  That study also concludes that the identification of a subset of patients at greatly increased risk of experiencing DR progression and onset of proliferative DR that cannot be assessed by ETDRS 7-field imaging, would have important implications for the evaluation and care of diabetic eye disease.

The significance of the additional peripheral information gleaned through UWF imaging in assessing the risk of future DR progression will develop with the data collected from this ongoing study.  The complete study and summary document, as well as our entire clinical library is available on our website. We encourage you to learn more about the clinical benefits of utilizing ultra-widefield optomap in your practice or clinic.

Sources:
Comparison of Early Treatment Diabetic Retinopathy Study Standard 7-Field Imaging with Ultra Widefield Imaging for Determining Severity of Diabetic Retinopathy. Journal of American Medicine, 2018
Peripheral Lesions Identified on Ultra Widefield Imaging Predict Increased Risk of Diabetic Retinopathy Progression Over Four Years. Ophthalmology 2015

Keeping yourself, your kids, and everyone’s peepers safe this Halloween!

With Halloween upon us, dressing up is all part of the fun for both children and adults.  To ensure Halloween is fun and safe for all, it is important to take proper precautions for safety.  Each year, the US hospital emergency rooms treat several hundred eye injuries related to Halloween costumes and masks. Additionally, it is often very easy for children to be less visible to drivers during evening hours.  Prevent Blindness® has provided some helpful safety times to keep in mind this Halloween:

Costumes and Safety

-Avoid costumes with masks, wigs, floppy hats or eye patches that block vision.
-Tie hats and scarves securely so they don’t slip over children’s eyes.
-Avoid costumes that drag on the ground to prevent tripping or falling
-Avoid pointed props such as spears, swords or wands that may harm other children’s eyes.
-Wear bright, reflective clothing or decorate costumes and bags with reflective tape/patches.
-Carry a bright flashlight to improve visibility.
-Do not ride a bike/scooter/skateboard or roller blade while wearing a costume.
-Obey all traffic signals—pedestrian and driver.
-Younger children should go with an adult while trick-or-treating around the neighborhood. Older children should trick-or-treat in groups.
-Use common sense. Never dart out between parked cars or hidden corners such as alleys. Avoid streets under construction.
-Don’t trick or-treat in busy commercial areas or where there is heavy traffic.
-Go trick-or-treating in daylight, as it is safer than going after dark.
-A safer option is to go to a Halloween party instead of trick-or-treating.

Treats

-Inspect all trick-or-treat items for signs of tampering before allowing children to eat them.
-Carefully inspect any toys or novelty items received by kids age 3 and younger. These may pose a choking hazard. Avoid giving young kids lollipops as the sticks can cause eye injuries.

Decorations

-Be sure your lawn, steps, porch and front door are well lit and free from obstacles.
-Keep candles and jack-o’-lanterns away from steps and porches outside, as costumes could brush against them and ignite. Inside, keep them away from curtains and other decorations to avoid causing a fire.

Older kids often complete their Halloween costumes with spooky cosmetic contact lenses. Remember that contact lenses are medical devices and require a valid prescription. Despite this rule however, these contacts are still widely available. If you or your child do decide to wear cosmetic contact lenses, be sure to follow safety guidelines  as to not suffer vision impairment. Decorative lenses should only be purchased from a licensed eye care professional, such as an Ophthalmologist or Optometrist. Also be sure to follow all the cleaning and sterilizing instructions carefully and if you experience redness, swelling or discomfort, see an eye care professional immediately.

 

Optos would like to wish you all a happy and safe Halloween. To protect your vision, make sure you and your family receive an annual retinal exam that includes optomap®.

https://www.verywellhealth.com/halloween-eye-safety-tips-3421885
https://www.preventblindness.org/tips-making-halloween-safe

Halloween Costumes and Eye Safety


Optos Introduces Monaco – The only clinically-validated, ultra-widefield retinal image with integrated OCT

In 2000, Optos delivered the first and only retinal imaging device that could capture beyond the vortex vessels of the retina. The ability to clearly image that much of the retina—in one capture, and in less than ½ second—significantly influenced the way eye care professionals examined their patients’ eyes. The core technology is based on a scanning laser ophthalmoscope and a unique ellipsoid mirror that create a virtual focal point inside the eye to enable the single capture of the central retina and periphery. For color images, green and red lasers are engaged simultaneously to allow visualization of retinal substructures from the sensory retina and retinal pigment epithelium to the choroid.

Over the years, Optos has continued to develop its hardware and software platforms – most recently delivering Monaco, the newest device providing new ways to enhance clinical exams.  It is the only ultra-widefield (UWF™) retinal imaging device with integrated OCT. Monaco produces a 200° single-capture optomap image in less than ½ second and also provides cross-sectional 40° OCT views of retinal structures. Monaco enables a rapid multi-modality capture featuring color, autofluorescence and OCT scans, for both eyes, in as little as two minutes.  UWF with integrated OCT saves time, space, and minimizes patient movement.  optomap images and OCT scans are correlated to facilitate pathology examination. Color, AF, and OCT images are shown in a single, comprehensive view on a single device.  The introduction of Monaco further differentiates Optos’ products with continued ease of use and speed of capture. OCT scans available with the device are: Line Scan, Raster Scan, Retina Topography Scan, Optic nerve Head (OnH) Topography Scan, and Retinal nerve Fiber layer (RnFl) Scan.

Optos technology has been a valuable asset to Werner Optometry in El Cajon, California for some time now.  Aaron Werner, OD joined his father, Rex Werner, OD, in the practice and has watched the technology improve immensely over time.  When given the opportunity to present Monaco in their practice, Dr. Werner knew this was the technology they had always wanted.

Dr. Werner was most surprised by how much time he saved in the exam room.  “There were efficiency scales that I never realized I could reach.  Think of the time it takes to settle a patient for an optomap, then walk the patient over to the OCT, re-enter data and then re position the patient.  It took about five minutes per patient,” he says, noting those some often take longer.  Dr. Werner adds that saving several minutes per patient allows space for an additional exam slot or two in a busy practice, but he himself appreciates the more advanced diagnostics he can get for all patients.

Dr. Werner, among many others, often feel there is never enough time to do everything the doctor wants to do during a visit.  “That’s at the top of the list.  We all think that if we had more time, we’d be able to do more.  The genius of combining and OCT with optomap imaging is really the way to get that time.”

Monaco, he says, is that rare combination of equipment that helps the staff save office time without compromising any of the quality or value of the exam.  In fact, it heightens it because it provides him with so much data before he even enters the exam room.  Monaco has also provided Dr. Werner with an excellent education tool.  “I am no longer a data collector in the exam room.  I have the data presented to me so that I can look at the results, interpret them and make a professional judgement on which direction we’re going to go. “Patients appreciate learning not only their retina anatomy but are also intrigued that the eyes can give so much data about their overall health.   Read Dr. Werner’s full testimonial here

To learn more about Monaco and other ultra-widefield devices from Optos, visit our website or contact us to discuss offerings with your local Optos representative.

Join us at Vision Expo West 2018!

Find out what’s new from Optos!

As the leaders in ultra-widefield (UWF™) retinal imaging technology, Optos would like to invite you to join us at the International Vision Expo West (VEW) September 26-29 at the Sands Expo in Las Vegas.    Explore what’s new at Optos by pre-scheduling your demonstration or stop by booth #MS6051 during the show.

Optos Announces Global Availability of Monaco — The Only Clinically-Validated, 200-Degree UWF Retinal Image with Integrated OCT

Optos has continued to develop hardware and software platforms— most recently delivering Monaco, the latest device which offers new ways to enhance clinical exams. It is the only UWF retinal imaging device with integrated OCT. Monaco produces a 200-degree, single-capture optomap image in less than ½ second and also provides cross-sectional, 40-degree OCT views of retinal structures. Monaco enables a rapid multi-modality capture featuring color, autofluorescence and OCT scans for both eyes in as little as two minutes. UWF with integrated OCT saves time, space and minimizes patient movement. The optomap images and OCT scans are correlated to facilitate pathology examination. Color, AF and OCT images are shown in a single, comprehensive view on a single device. The introduction of Monaco further differentiates our products with continued ease of use and speed of capture. OCT scans available with the device are: Line Scan, Raster Scan, Retina Topography Scan, Optic nerve Head (OnH) Topography Scan and Retinal nerve Fiber layer (RnFl) Scan.

We have continued development on OptosAdvance™, the comprehensive image management solution for eyecare professionals. It enables clinicians to review, annotate, securely refer and archive images from many eyecare diagnostic devices in their practices using a single, industry-standard DICOM solution. OptosAdvance  provides an ‘all-in-one’ solution for managing clinical eyecare data from any browser. Additionally, data within the screen views can be arranged according to individual users’ preferences.

In addition, Optos offers OptosCloud — the latest storage solution for eyecare professionals utilizing OptosAdvance  Enable your data to be secure and safe while making it more accessible from anywhere.

For more information regarding our offerings at VEW, or if you have any questions about our UWF retinal imaging please call 800-854-3039 or visit optos.is/MonacoUWFandOCT

We look forward to seeing you at the show!

optomap Enables Detection, Diagnosis, and Guides Treatment in Age-Related Ocular Pathology

September is Healthy Aging month, however despite age related changes to vision, ocular health is often overlooked.  As the aging population grows, adding the first influx of generation X to the baby boomers in the over 50 demographics, the incidences of glaucoma and Age-related Macular Degeneration (AMD) are also on the rise.

Recent studies have demonstrated how optomap ultra-widefield™ (UWF) retinal imaging is fulfilling a need in supporting the detection and management of both ocular and systemic diseases associated with aging. UWF imaging provides a high resolution, single-capture image of 82% (or 200 degrees) of the retina.  Studies have confirmed that the resolution of the optomap image – is comparable to fundus photography – which captures 11% of the retina, in detection of diseases such as diabetic retinopathy, AMD and uveitis.  Additionally, studies have found that the additional area captured by optomap can enhance the ability to detect, diagnose and manage diseases in comparison to fundus photography and be captured more efficiently.  UWF is being increasingly used in optometric and ophthalmic settings and enables eye care professionals to detect, diagnose, document and treat ocular pathology including retinal disease that may first present in the periphery.

Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in adults over age 50. The Centers for Disease Control and Prevention estimate that by the year 2020, 196 million people worldwide will be living with some form of AMD.

Although there have been many discoveries in the understanding of the causes of AMD, including links to genetics, there remains much unknown about this complicated, degenerative disease. Over time the retinal periphery has been able to be more easily studied in early AMD to determine the value in the detection and/or monitoring of the disease.  However, with the advent of multi-modality UWF imaging, novel studies are beginning to demonstrate this value. Color optomap imaging captures the structure and fundus autofluorescence (FAF) the function of the Retinal Pigment Epithelium (RPE) which is where AMD manifests within the eye. Studies have revealed that 97% of patients with AMD have evidence of the disease in the far periphery.

This outcome demonstrated that drusen were seen in a majority of eyes, strongly indicating that AMD is more than a macular condition but one that involves the entire retina. This is being investigated in a further study that will determine whether these peripheral changes are associated with the progression of the disease.   Read the Full Article

Glaucoma is another primary cause of blindness worldwide, affecting an estimated 70 million people. While early detection is key to taking steps to prevent vision loss, glaucomatous vision impairment is irreversible.  Unfortunately, glaucoma can be asymptomatic until the late stages, at which time the prognosis is poor.

The gold standard for detection and diagnosis of glaucoma is a clinical examination with dilated slit lamp biomicroscopy conducted by a glaucoma specialist.  However, this level of expertise is not always feasible or readily available to broadly evaluate an aging population. Exam efficiency has been increasingly addressed via use of color digital stereoscopic photography and/or retinal tomography via SD-OCT.

A recent  study explored the potential suitability of ultra-widefield retinal imaging in diagnosing glaucoma in situations where slit-lamp biomicroscopy or digital color stereoscopy are not available. The purpose of the study was to evaluate the reproducibility and validity of UWF in estimating Vertical Cup to Disc Ratio (VCDR) measurements and was the first study of its kind to explore whether optomap imaging could be suitable as a diagnostic support tool for glaucoma.

The study evaluated the data from color digital stereoscopic fundus images (CDS) and UWF images.  All the photographs and images were graded by two masked trained graders and one masked glaucoma specialist. The optomap images were graded using the ‘measure distance’ tool on the OptosAdvancesoftware, to measure and record cup to disc ratio (CDR).

The study demonstrated an almost perfect agreement between CDS and optomap when assessed by the glaucoma specialist.   The study concludes that optomap imaging has a high reproducibility in evaluating VCDR and agreement with stereoscopic optic disc imaging and indicates that UWF imaging may be suitable for glaucoma evaluation in settings where CDS is not available. Read the Full Article here….
Or visit our website to learn more about clinical studies utilizing optomap technology

https://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/macular-degeneration
http://www.allaboutvision.com/conditions/amd.htm
https://nei.nih.gov/health/maculardegen/armd_facts
https://www.aaojournal.org/article/S0161-6420(16)31491-9/abstract
http://www.aaojournal.org/article/S0161-6420(16)31491-9/fulltext