2013 Diagnostic Instrument Buyers' Guide

Tracking the OCT Revolution

How OCT has transformed the clinical landscape and earned its standing as an established pillar of eye care at all levels.

BY FRANK CELIA, CONTRIBUTING EDITOR

OCT arrived at an opportune moment in medical history… just in time to play handmaiden to the success of anti-VEGF retinal therapy, arguably the most significant vision-care achievement of our time. Because anti-VEGF drugs, and therapies such as lasers and steroids, produce limited durations of effect and better outcomes on early-stage disease, there exists a need for heightened monitoring of existing retinal patients and quicker diagnosis of new ones. OCT excels at both.

OCT also continues to impact glaucoma, though advancement here has been slower. This is likely due not only to glaucoma’s more elusive pathogenesis, but also to the more gradual progression of the disease. Whereas a condition such as diabetic retinopathy develops over a period of months, glaucoma can take years or even decades to diagnose or progress. So, for example, though incremental breakthroughs have been made in glaucomatous OCT progression analysis, thus far, none have involved spectral domain machines. Studies are ongoing.

Outside subspecialties, OCT can help resolve vague, general vision complaints as well. Optometrists tell of patients with no known refractive error who demonstrate 20/25 vision and upon routine OCT examination reveal vitreomacular traction or an incipient macular hole.

In short, this fast, non-invasive imaging technique holds an important place in a wide range of eyecare endeavors. This article explores some of the practical uses for OCT and how they might evolve in the future.

Most Eyes Have It

Like any maturing industry, OCT manufacturers have begun to move toward a state of equilibrium wherein a handful of established brands dominate the market (OPKO Health, Inc. sold its OCT assets to retinal photography company Optos, Inc., in 2011, for example). In such environments, products begin to resemble each other as industry standards emerge. One such standard has been the rise of gaze-tracking systems.

Although they employ widely different methodology, all tracking systems recognize when a patient’s eye movement or blink has skewed an OCT scan, and then automatically perform an additional scan to correct the error. Eye tracking is often advertised as a “time saver,” but the technology’s true value lies in guarding against operator error. A skilled, attentive OCT operator should notice when eye movement distorts a scan, and then simply re-take the scan. Unfortunately, this doesn’t always happen. By automating this task, eye tracking removes image-quality decisions from human hands, which provides more accurate results and simplifies the training process for staff.

Perhaps the most noteworthy clinical advantage of eye tracking is its proven precision in calibrating the registration of images from one office visit to the next, sometimes down to the micron,¹ creating enormous monitoring potential over successive scans. “If I’m treating a patient with the goal of decreasing retinal thickening, it’s ideal to have each scan image at the exact same location,” says Ronald C. Gentile, MD, FACS, FASRS, professor of ophthalmology at The New York Eye & Ear Infirmary. “This provides a more accurate and quantitative map of the location of the decrease in retinal thickening and also the opposite, indicating where the thickening may be getting worse. This technology can actually tell you in microns how much better or worse the retinal thickening is.”

Gaze tracking holds so much appeal, almost every major OCT manufacturer now offers it, the sole exception being Bioptigen (See “Coordinated Movement,” page 14-S). This was a conscious decision based on Bioptigen’s unique market niche, says CEO Eric L. Buckland, PhD. “There are many numbers thrown around about imaging, but we feel safe saying our machines are unique in their ability to scan at high density, at high speed,” Dr. Buckland explains. “With high-density scans captured without a need for ‘averaging’ images, we better sample pathology that is within our field of view. Typically, in the systems that offer eye tracking, they take some of the computer memory we expend on collecting data and put it toward averaging the images to reduce image noise.” This creates a high-contrast image well suited to a busy private practice, he concedes — but also an image containing less information. “It’s fair to say eye tracking can add real value to a busy clinical practice, but Bioptigen’s research-oriented customers want unbiased data and richer information content.”

In patients with too much movement, eye tracking can fail, but the Bioptigen system continues to collect data, he says. Where others offer eye tracking, Bioptigen provides user-defined protocols for research studies that rely on a multiplicity of scans to visualize pathology, allowing accurate repetition across patients and times within a research program, according to Dr. Buckland.

Carl Zeiss Meditec, with more than 10,000 OCT devices in the field, also hesitated before developing an eye tracking system, wary about tradeoffs in data density and scan time spent recalibrating and re-shooting. But ultimately the company decided it was worth adding it as an option to achieve better image quality and interscan registration, according to Christine Ritter, senior director of OCT imaging. “Eye tracking gives us some improvement in the reproducibility of the macular thickness measures on the dense cube rasters, on the order of two or three microns — not a huge benefit, but it’s there for difficult cases where the patients do not fixate well,” she says. “In addition to the raster cube improvements, tracking also enables a series of best-of-the-best quality b-scans that can be placed at exactly the same location every visit. When there’s a difficult patient, or when you want to examine the subtle details of a lesion using the highest quality image, that’s the time to use our FastTrac™ tracking feature.”

Can Extensive Data Help Answer Enduring Questions?

Researchers remain hopeful that OCT technology’s vast computer memory and large population databases may one day help untangle some of the mysteries surrounding glaucoma. Profound questions endure: What metric best defines and measures disease progression? Does progression occur linearly at a fixed rate, or stepwise with great clumps of cells dying at variant speeds? Which computer algorithm is most useful, event-based or trend-based analysis?

Limited progress has been made in answering these questions. For example, trend-based analysis appears to be edging out event-based formulas as the preferred metric. As one well-regarded study put it: “Measuring the rate of change in [retinal nerve fiber layer] thickness [only achievable with trend-based analysis] would serve as a new paradigm for observing and managing patients with glaucoma.”²

The same paper tentatively suggests glaucoma progresses linearly, while conceding that additional and lengthy follow up is needed to confirm that hypothesis.²

The theory that structural damage, as measured by diagnostics such as OCT, precedes functional damage, as measured by visual field testing — another hotly debated glaucoma topic — appears to be gaining ground.³ One recent study suggests “progression as measured by a decrease in RNFL thickness is more noticeable than is progression assessed by visual field measurements in early-stage glaucoma patients, whereas the reverse is true when the disease is more advanced.”³

Flexible Usage

Last year, the FDA cleared Bioptigen’s Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for use on pediatric patients. The system’s handheld scanner can image patients of any age, from premature and neonatal infants to adults, whether upright or supine, ambulatory or confined. The ability to capture sharp images rapidly and at high density without averaging is what makes handheld OCT feasible, according to the company.

“Our system is enabling new levels of research,” says Dr. Buckland. “There are a number of trials using our system to evaluate how the retina develops right after birth.” A deeper understanding of how healthy retinas grow may help researchers develop ways to treat retinopathy of prematurity (ROP), which continues to be a problem for premature infants, he notes.

The retina undergoes rapid development up to age two, and then significant growth up to age five. Here too OCTs could reveal practical information, says Dr. Buckland: “Certainly a 2-year-old toddler cannot be imaged by a standard clinical lane [OCT] system. And for subjects, young or old, who are under anesthesia, our mobile handheld systems extend the application to the operating theater.”

Raising the Refractive Bar

OCT technology can play a significant role in refractions, especially in cases of vitreomacular traction (VMT), which often begin as vague visual complaints. “Prior to the advent of OCT, VMT was a rare diagnosis, imperceivable using fundoscopic evaluation alone,” says Diana Shechtman, OD, FAAO, an associate professor of optometry at Nova Southwestern University. “Today, OCT aids in the diagnosis of VMT, which is now recognized as the pathogenesis of a spectrum of maculopathies including macular holes and macular edema.”

Co-management opportunities abound. The early and intermediate stages of dry AMD can last for years, even decades, Dr. Shechtman notes. “In the early or even moderate stage of the disease, so long as the optometrist has the capabilities and instruments, we can certainly follow these patients and play a critical role in their management by making the proper nutritional supplementation recommendations and educating them about lifestyle modification.”

Moving Toward Standardization

As trend-based analysis emerges as the likely preferred algorithm for monitoring glaucoma, one physician is glad to see the OCT industry moving toward agreed-upon industry standards and common functionalities such as eye tracking. “To perform trend analysis, we need stable software platforms, and we’re starting to see that with the spectral domain OCTs,” says Nathan M. Radcliffe, MD, director of glaucoma service at Weill Cornell Medical College. Accurate trend analysis requires at least five scans (ideally over many years) with an identical acquisition protocol. “If these software developers change their minds every 6 months, we’ll have to keep going back to square one,” he says. “I’m happy the CIRRUS has had the same data cube since 2007. That’s the kind of stability we need.”■

PACS: Invaluable and Inevitable

Your image and data library is growing. You need a system that stores, organizes and presents it quickly on a single screen, anywhere.

BY ERIN MURPHY, CONTRIBUTING EDITOR

As ophthalmology gains an ever more sophisticated range of imaging and diagnostic applications, ophthalmic facilities from the solo practice to the large health system find that the resulting multitude of large files require a more powerful infrastructure.

After all, you can’t continue going from device to device, using a half dozen viewing software programs to see your exam data, nor can you keep printing images for paper files. You need to view images and data at the same time on one screen. You need to access records quickly — in your office, at the hospital or in an ASC from your laptop, tablet or phone. You need to go create an environment in which technological advantages support not only clinical diagnosis, but also an efficient workflow.

The missing piece is a picture archiving and communication system (PACS), sometimes called an image management system. These systems automatically collect and store images and other data from all practice devices, allowing you access via a single interface. The interface allows you to measure, annotate and perform all of the tasks you might currently be doing on the device software, but with PACS, you can perform tasks for any number of devices on a single interface and screen. Many systems use the Digital Imaging and Communications in Medicine (DICOM) standard for image management, but PACs don’t require all of your devices to be DICOM based. The systems are designed for speed, so you can access data quickly, even using mobile devices. What’s more, the PACS integrates with your electronic health record (EHR) system, representing a final leg in the long paperless journey.

Do You Need a PACS?

Depending on the size of your practice and how much imaging is performed, you might already have a PACS, see the need for one or wonder whether it’s worth the investment. Consider one ophthalmologist’s take on this.

“For ophthalmologists, a PACS is a must have,” says Michele C. Lim, MD, Associate Professor of Ophthalmology and Medical Director at the University of California, Davis. “I always say that we ‘live and die by our images’ because we are so dependent on images from a range of modalities to diagnose and treat our patients. A PACS grabs the images from our devices, puts them all on one server and then delivers them to us via a web browser. We can access images from anywhere, including the clinic, hospital and home.”

Accessibility isn’t the only reason to get a PACS. There are clinical advantages as well. John Trefethen is Market Development Manager at Carl Zeiss Meditec, Inc., makers of FORUM Eye Care Data Management. “Without a good PACS, physicians are forced to review static reports and compressed image formats with limited detail. A system like FORUM lets them review combined reports and high-res images side by side with just a few clicks,” he says. “With the onset of ‘big data’ and a greater emphasis on proving meaningful use, a good PACS will constantly improve a physician’s ability to analyze progressive change over time and quantify their measurements with the emphasis on improving patients’ quality of life.”

Still, to many physicians, the idea of implementing a PACS sounds is about as appealing as implementing an EHR system. But unlike many experiences such as bringing an EHR online, a PACS makes its time- and money-saving efficiencies known right away, according to Rich Amador, iProduct Manager for Eyecare at Canon Healthcare Solutions, developers of imageSPECTRUM. “Introducing a PACS requires ‘re-engineering’ a department, which is a daunting task. But in other specialties, such as radiology, they found that PACS increased efficiencies and made better use of everyone’s time. Prior to PACS, no one stopped to think how much time and cost was spent fixing a simple error related to erroneous patient demographics. Practices with PACS quickly find additional time, allowing them to see a few more patients each day. Hard costs like paper, printer ink, and folders are nearly eliminated.”

“The ROI is more than just saving money on paper and ink,” adds Randall Walter, Regional Vice President of EyeCare Solutions at Merge Healthcare, maker of PACS for several specialties, including the Merge EyeCare PACS. “Physicians who don’t have a PACS often waste time going from modality to modality, using multiple vendors’ proprietary review tools. Offices with many physicians or satellites misplace studies and drain employee time finding them. With a system like Merge EyeCare PACS, all images from more than 200 devices reside in a single web-based viewer with DICOM storage, query and retrieval. And by providing true integration to EHRs without slowing things down, it also solves a necessary component of meaningful use stage two.”

The PACS-EHR Relationship

Are you already using an EHR system or preparing to implement one? Dr. Lim, who has been using a PACS at UC Davis since 2004, says that in addition to its advantages for storing and accessing images, a PACS plays an essential role in eliminating reliance on paper records. “As we convert to EHR, the paper chart goes away. Where then do you place your imaging results? The PACS allows us to store and view our images digitally, thus helping us convert to a paperless office. Paperless documentation helps us clinically and supports long-term documentation and billing. I’m not sure how we survived before our PACS was in place.”

It isn’t hard to find a PACS that integrates with EHRs – they all do. You just have to be sure the PACS you purchase can be integrated with your specific her system. If you don’t have an EHR system, a PACS could be a good start.

Jane T. Shuman, COT, COE, OCS, President of Eyetechs, Inc., a consulting firm in Boston, sees the need for a PACS in many of her clients’ practices, particularly as the system relates to the her system. “I’m seeing more and more practices that are using EHR on a slow, bogged-down server. Their in-house imaging system isn’t sufficient. I recommend getting a PACS. The beauty of these systems is that clinicians can look at multiple images in the EHR much like they would in a paper chart, viewing different modalities side by side,” she says. “The price may not be easily justified in a general ophthalmology solo practice, but it’s a good investment for any size facility that’s performing a large number of diagnostics and needs fast storage, management and access. If a practice doesn’t have an EHR system yet, I recommend that they implement it gradually, starting with a PACS to get them used to accessing images stored on a single server.”

Some EHR systems have their own built-in PACS, like the Medflow EHR system with an embedded DICOM-based PACS from Medflow, Inc. Vice President of Sales and Marketing James Messier explains the advantages integration. “A PACS gives providers better access to image data, ensures proper data handling, minimizes demographic entries and mistakes and combines multiple modality results into a single viewer,” he says. “With the DICOM workflow, the PACS supports automatic ordering by modality and study type, automatic storage, automatic notification that an image is available for interpretation and automatic billing once an interpretation report is complete.”

The efficiencies gained through PACS/EHR integration are also a driving force at VersaSuite Integrated Healthcare Solutions, maker of the Versasuite Ophthalmology. “A PACS is a great investment if it’s integrated with your EHR solution, removing the tedious task of associating images with patient records, storing your images and notes digitally, and streamlining your workflow. A PACS makes it possible to review more images in the same time by cutting time spent on administrative tasks that can bottleneck your process,” explains VersaSuite Regional Sales Manager Tushar Jain. “The Versasuite Ophthalmology Solution takes that several steps beyond PACS/EHR integration to work with your practice management system, optical area, patient portal, payroll, marketing, accounting and human resources. The products were built together and are tightly intertwined, enabling unprecedented data accessibility across traditionally separate software products.”

DICOM is Key

What are you looking for in a PACS? Start with DICOM standardization. DICOM is a great concept, but many practitioners worry that a DICOM-based PACS won’t work with their legacy equipment. But you don’t need to re-outfit your lanes immediately. The idea is to ensure that your PACS is DICOM compatible and works with your legacy equipment; your devices will catch up to the DICOM standard over time with normal replacements and upgrades.

“Ophthalmology utilizes a variety of devices to acquire images, many of which are non-DICOM and/or proprietary. INFINITT Ophthalmic PACS allows you to capture all data from a patient’s visit — no matter what media — and to store, retrieve, view, enhance and print from a single workstation,” explains Bob Blake from INFINITT North America Inc., makers of INFINITT Ophthalmic PACS. “INFINITT Ophthalmic PACS is a web-based image management solution that acquires data directly from new and legacy ophthalmology devices, both DICOM and non-DICOM. It reduces data entry and enables fast report generation by creating an integrated viewing environment that’s accessible from any computer, tablet or smartphone.”

INFINITT certainly isn’t the only company offering connectivity for a broad range of devices. Look for a DICOM-compliant system that best suits your needs.

“The big thing to look for is DICOM compliance,” says Dr. Lim. “We want vendors that adhere to this standard so we can exchange images freely. No company uses 100% DICOM-compliant images, but it’s good to invest in a company that’s working toward DICOM compliance. The American Academy of Ophthalmology (AAO) should be issuing a list of eye PACS vendors detailing where they are with their adherence to the DICOM standard.”

James Messier from Medflow looks forward to the future of DICOM-based technologies. “Medflow has worked for years alongside the AAO to help develop DICOM Workgroup 9 and IHE for Eye Care standards. In the future, DICOM will enable imaging devices and EHRs to be plug and play — and part of government Meaningful Use criteria. Therefore, a practice should not invest in any testing equipment that cannot support DICOM,” he says. “What’s more, DICOM compliance should be tested and validated by the [Radiological Society of North America] RSNA during one of their annual Connect-a-Thons, lending third-party validation to DICOM claims.”

imageSPECTRUM is uniquely DICOM-centric, filling a different function than standard PACS. “imageSPECTRUM version 5, Server and Review emulates all the functionality typically found in a PACS product, but isn’t considered a PACS,” explains Amador. “The server and review workstations communicate through DICOM, rather than any proprietary interface, so they work in any network environment, giving consumers the freedom to buy the best ‘server’ and the best ‘review’ products. This is a better investment than other PACS because it permits practices to change software interfaces in the future when circumstances change.”

Other Features to Seek

With DICOM checked off your list, what else should you look for in a PACS? One choice is a web, or cloud-based system versus a server-based system. Companies can outline the security measures they employ for either choice. Often, the decision is a matter of geography. A web-based system can be viewed from any locations you permit, while local servers are accessible only from inside your building or by logging into the server externally.

There are many other features to consider as well. Shuman’s priority is to ensure that her clients’ reimbursements come through. “I want my clients to look for a PACS that incorporates the documentation they need to qualify the codes they submit. It should make their interpretation clear,” she says. “For the best efficiency, doctors should also be able to tile images, zoom and annotate directly on the image or record instead of in a separate document.”

And, like any technology, a PACS needs tech help. “Look for a company that has excellent support,” advises Dr. Lim. “Over the years, as our database has grown and we’ve added new devices, we had to hire a full-time in-house IT expert. That’s not an option in many practices, so I recommend going with a company that has affordable support services from which you can get immediate help in the middle of your busy day.”

Bob Gibson, Vice President of Marketing at Topcon Medical Systems, Inc., makers of Synergy, says affordability is among his company’s goals. “Synergy is web-based and built for ophthalmology. It stores and manages data from more than 125 different ophthalmic devices from various manufacturers, including non-DICOM legacy devices, and integrates easily with electronic patient records,” he says. “Another one of our goals is to be economical while continually improving Synergy. We do that by including no-charge interfaces with all Topcon products. And being web-based, there’s no need for users to install software on their computers (PC or MAC), ensuring that all users can have access to Synergy without the time and cost of deploying software upgrades.”

If you want an ophthalmology PACS with functionality designed for your devices and your specialty, you have many choices. Some companies that offer ophthalmology PACS are 100% eyecare centered, while others build PACS for several different specialties, such as radiology or oncology, as well as ophthalmology. Either way, you should be able to find one that fits your practice.

“Ophthalmology is all we do with AXIS,” says Matt Carnevale, Executive Vice-President and Chief Technical Officer at Sonomed Escalon, makers of the AXIS image management system. “Our PACS system houses raw data from numerous devices and vendors, then presents them in a manner that’s customized specifically for ophthalmology. The display screens provide familiar functionality for each imaging device while eliminating the need to tie up those devices. For example, ophthalmologists can create a montage, perform a PDT treatment, scan through an OCT data cube in high resolution and measure change in retinal thickness, all from any computer or mobile device in the world.”

Finally, Paul G. Chace recommends that practitioners go beyond a PACS’ basic functions. The CEO and Founder of Chace and Associates Technologies, LLC, makers of iViews Imaging System says, “The number one reason to invest in a PACS is to store patient records for the required time period. Systems like iViews were created to collect and store meaningful data sets, video, and images for over 170 devices and counting,” he says. “But a meaningful PACS in ophthalmology must go beyond storing and retrieving static images. All available data sets must be instantly accessible to clinicians, technicians, claims departments and administrators in a way that supports their work. Physicians and [staff] should look for an ophthalmology PACS that also is a medical informatics application, combining a solid viewing application with the data from their instruments for meaningful therapy tracking.”

The Future of PACS

The second you make a technology investment it begins to age — and sometimes it may become obsolete. However, the need for efficient management of your large image and data archive is likely to grow over time.

“As more and more ophthalmology hardware vendors support DICOM and modality work lists, the need for permanent image storage will only increase, while proprietary data storage and review tools from device manufacturers will go by the wayside,” explains Walter.

Tasha Jain points to the critical role that the PACS will play as other technologies advance. “PACS technology is going to keep pace with the blistering rate of development of imaging technology complimenting its evolution and continuing to improve patient care by giving physicians a way to more easily view and analyze these images.”

IT world aside, there’s another key player that will help PACS evolve: you. “Read any article on PACS, and the common buzzwords of the day are IHE, DICOM and HL7, leading decision makers to believe that as long as these words apply, they’re making the right choice. While these standards are important, they only address how we move data from one place to another,” says Carnevale. “The future of this technology comes down to one word: functionality. The functionality of what you can do with the data after it’s in the PACS system is what makes the difference. The future is how we expand on that functionality.”

To enhance that real-world functionality, PACS companies work with physicians like you, as well as other key players in practice management and patient workflow. PACS vendors can tell you how their companies work with people in the field, as well as how they will listen and respond to your feedback if you adopt their product. With so many facilities moving to a PACS, the sheer volume of feedback will likely ensure that there’s a system to meet your practice needs. ■

To download a PDF of the 2013 Diagnostic Instrument Buying Guide for Product Listings and Detailed Listings of Key Diagnostic Instruments, click here.