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Read PDF Edition THE MEDICARE APPEALS PROCESS P. 16 • RESEARCH BRIEFS P. 60 OCTA AND GLAUCOMA P. 62 • THE LATEST TECHNOLOGY AND DRUGS P. 70 WILLS EYE RESIDENT CASE SERIES P. 77 Review of Ophthalmology Vol. XXV, No. 5 • May 2019 • Charting Your Own Course • The Questionable Cataract • EHR Glaucoma Own Course • The Issues • Uveitic 2019 • Charting Your No. 5 • May Review of Ophthalmology Vol. XXV, MAMAYY 22019019 reviewofophthalmology.comreviewofophthalmology.com CHARTING YOUR OWN COURSE Experts share tips on how to go solo, but note that there are many challenges to overcome as well. P. 20 ALSO INSIDE: • EHR: Room for Improvement? P. 32 • The Questionable Cataract: Who Decides? P. 40 • How to Manage Uveitic Glaucoma P. 48 • Strong Moves for Weak Zonules P. 54 001_rp0519_fc.indd 1 4/16/19 10:03 AM +3.25 D RP0519_J & J Surgical.indd 1 4/5/19 9:57 AM REVIEW NEWS Volume XXV • No. 5 • May 2019 Calcium Intake and Age- Related Macular Degeneration In a recently published study, a secondary the association between calcium in- analysis of patients enrolled in the take and AMD have produced mixed Age-Related Eye Disease Study was results. Findings from the Blue conducted to determine whether an Mountains Eye Study show that Emily Chew, MD Emily Chew, association exists between dietary and calcium may be an important factor supplementary calcium intake and in limiting AMD development/pro- age-related macular degeneration. gression.1 Conversely, fi ndings from Emily Chew, MD, director of the di- the Nutrition Examination Survey vision of epidemiology and clinical ap- suggest that increased calcium in- plications at the National Eye Institute take is harmful in terms of macular at the National Institutes of Health, degeneration.2 However, Dr. Chew conducted the retrospective analy- says the latter was only based on sis. She says studies have suggested cross-sectional data. “[In our analy- calcium might play a role in macular sis], we looked longitudinally, using a degeneration, so she wanted to see if dietary and supplemental calcium baseline to see how calcium is asso- it had any effect on the disease. “We intake and the risk of developing ciated with worsening of AMD over were not only interested in dietary in- AMD, as well as the disease’s pro- time,” she says. “We think the longi- take of calcium, but also supplemen- gression to intermediate and late tudinal data was more powerful.” tary intake since it’s common, particu- stages. A total of 4,751 participants Similar to fi ndings in the Blue larly for women with osteoporosis, to who had no macular degeneration, Mountains Eye study, other results be taking calcium supplements,” says as well as those with mild, moder- include an inconsistent associa- Dr. Chew. ate and severe disease, were fol- tion between calcium consumption The pathology of AMD is poorly lowed for a mean of 10 years. The and the different stages of AMD. understood, and experts are still trying study found a signifi cant association Dr. Chew says that there are signs to determine its risk factors. “Unfor- between higher levels of dietary and showing changes occurring at dif- tunately, we don’t know the pathway supplementary calcium intake and ferent stages of the disease. “We through which macular degeneration a lower incidence of progression to think there’s more than one pathway occurs,” says Dr. Chew. “We can only late AMD. Dr. Chew notes that addi- in which macular degeneration oc- understand it by looking at risk factors, tional fi ndings showed that patients curs,” she says. “We know that cer- genetics, studying long-term follow- weren’t harmed by the increased cal- tain genetic associations are impor- up and seeing what drugs and dietary cium intake, similar to fi ndings from tant for getting the disease, but for it infl uences might be affecting it.” She the Blue Mountains Eye Study. to progress, other factors may come says it’s not surprising that calcium may Dr. Chew notes that, since the into play.” affect macular degeneration, however. study was retrospective, they don’t With this in mind, the researchers “It’s been recognized and demon- know whether any biases exist or if say additional study is required. “We strated by scientists that the heart of the individuals involved are typical of have new ideas suggesting calcium drusen, which are the hallmark for the general public. Additionally, she might be important but we can’t [determining] macular degeneration, adds that most of the subjects were say whether increased intake pre- is actually calcium,” she says. white, so the data may not apply to vents macular degeneration without Retrospectively, the study investi- all groups of people. a randomized trial that studies it,” gated possible associations between Previous studies that looked into (Continued on page 8 May 2019 | reviewofophthalmology.com | 3 003_rp0519_news.indd 3 4/16/19 3:02 PM Ophthalmic Product Development Insights Aki Tobaru, Hiro Matsuda, PhD, & Matthew Chapin • Ora Inc., Andover, Mass. REVIEW Matthew Chapin and Ryan Bouchard Basics of Medical Devices for the New Entrepreneur he ARVO and ASCRS meetings are ing through the Premarket Notifi cation mology, such as radiology. Image manage- upon us, and these conferences process, or 510(k). When a 510(k) is granted, ment and manipulation are common in other Trepresent opportunities for physician- the device’s sponsor is then allowed to therapeutic areas as well. entrepreneurs to build momentum in their say the product is cleared to be marketed. Class III devices require a Pre-Market development of their new devices, get input The 510(k) process grants clearance, not Approval (PMA) to demonstrate safety and from colleagues and meet with potential approval (this is a common mistake in how effi cacy, and are typically interventions, partners and investors. In this column, sponsors talk about the process and one that such as a retinal prosthesis or an IOL. (It’s a we’ll provide a brief overview of regulatory the FDA takes very seriously.) In a 510(k), little-known fact that extended wear contact considerations and pearls related to the de- there must be a comparison of the investiga- lenses are actually Class III devices, too— velopment of new devices in ophthalmology tional device to one or more similar, legally the agency treats daily wear and extended for the fi rst-time physician-entrepreneur. marketed devices (called predicate devices). wear differently based on the underlying In ophthalmology, medical devices For a device to be cleared for marketing risks.) include such things as hand-held surgical by the FDA, the 510(k) submission must For Class III devices, the FDA has 180 days instruments, sutures, diagnostic imagers, demonstrate that the investigational device to review the PMA and make a determina- intraocular lenses, contact lenses, lasers, is ‘substantially equivalent’ to the predicate tion for approval. PMA approval is based on and software for image analysis, smart device. Once submitted, the FDA has 90 a determination by the agency that the PMA phones and tablets. The government agency days to review the 510(k). In ophthalmology, contains suffi cient valid scientifi c evidence charged with evaluating these devices for a large portion of the devices commonly to ensure that the device is safe and ef- approval and overseeing their manufactur- seen today that are cleared through the fective for its intended use(s). When a PMA ing, performance and safety is the Center for 510(k) process, such as optical coherence is granted, these devices are considered tomographers, artifi cial-intelligence-based Devices and Radiological Health, a branch of approved by the FDA. programs and some lasers, require clinical the FDA. The De Novo pathway is used for a new trials. device that hasn’t previously been classi- Before a company can begin selling a med- fi ed, and there’s a chance that it could be ical device, it needs to prepare what’s known considered Class II based on the criteria as a premarket submission. The nature of discussed earlier. The process was this regulatory fi ling is largely based on modifi ed in 2012 to not require a the classifi cation of the device. Devices 510(k) submission in advance. Upon generally fall into one of three classes submission of the request, the FDA will based on technology complexity, intend- conduct a review of substantial equiva- ed use (i.e., diagnostic or intervention) lence, as well as determine whether a and, to an extent, their risk profi le. Most new product code is warranted, which of the classifi cations in ophthalmology were would allow the device to be marketed. defi ned in the late 1980s, but new ones are Some very important recent advances in still generated today, and sometimes a clas- Selecting the predicate device for compari- ophthalmology have come via the De Novo sifi cation will change as a technology and son is half the battle. Substantial equiva- pathway, such as the fi rst AI screening its uses are better understood. Classifi cation lence is determined if the investigational program for diabetics from IDx, and a new determines the extent of regulatory control device, in comparison to a predicate: dry-eye treatment from Oculeve (now owned required by the FDA for the device to be • has the same intended use and has the by Allergan). A key element of this program marketed, and the type of preclinical and same technological characteristics; or allows the new products to serve as predi- clinical testing required. • has the same intended use but has dif- cates, which may make it easier to bring ferent technological characteristics and the new technology to patients in the future.
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