Quick Hits
Ultrawide-field imaging helps keep a closer eye on diabetic retinopathy
New study uses UWF imaging to link periphery retinal lesions with cases of DR.
By Robert Stoneback, Associate Editor
The Joslin Diabetes Center has found a connection between periphery retinal lesions and diabetic retinopathy, which could result in earlier diagnosis for some patients, according to new research. According to one ophthalmologist, this will allow doctors to detect diseases in patients that would previously go unnoticed.
Lead investigator Paolo Silva, MD, reports that the presence of these lesions could indicate a greater risk that diabetic retinopathy will progress more rapidly.1
“With the UWF [ultrawide field] angiograms, we can more accurately measure the extent of nonperfusion in the peripheral [than traditional imaging] and examine how this relates to the increased risk for retinopathy progression over time,” says Dr. Silva, via a release. The nonperfused areas matched up very closely with those peripheral lesions detected when these patients’ eyes were scanned using normal UWF imaging, according to Dr. Silva.
Ultrawide-field angiography imaging was used to examine the eyes of 37 patients with diabetes and varying levels of retinopathy, ranging from no disease to advanced stages. UWF images with no angiography were taken at the same visit.2
The UWF imaging, which can view most of the retina in a single image, was used to identify areas that had lost retinal blood flow, or retinal nonperfusion. Traditional eye imaging, the release says, creates an image by combining seven smaller photos, but only covers about a third of the lesions on the retina’s periphery. Traditional imaging doesn’t detect these peripheral lesions.1
Jose Agustin Martinez, MD, of Austin Retina Associates in Texas, says UWF imaging may not make a difference for 90% of patients, as the 30-degree field used by traditional eye imaging can still catch most major problems. However, “for that 10% it will make a huge difference,” since the UWF imaging can catch the periphery lesions that would normally go unnoticed and allow more cases of diabetic eye disease to be identified.
Using UWF imaging, Dr. Martinez believes, also allows doctors to diagnose such patients earlier.
Diabetic retinopathy rates growing
Diabetic retinopathy is a disease on the rise in America. By 2030, the number afflicted is expected to double over those from 2010, with cases increasing most among whites and Hispanics. (Source: https://nei.nih.gov/eyedata/diabetic)
Total cases of diabetic retinopathy across U.S. population
“The earlier we intervene, the better patients do,” he says.
UWF imaging will also be helpful in screening programs, designed to test the eyes of patients currently not evaluated by eye-care specialists. Studies have shown that anywhere from 50% to 70% of diabetic patients do not have their eyes examined, which means getting them into these screening programs is even more important, says Dr. Martinez. (See Telehealth reaches the unreachable, page 32.)
REFERENCES
1. Joslin Diabetes Center. Damage in Retinal Periphery Closely Matches Loss of Blood Flow in People with Diabetes. http://www.joslin.org/news/Damage-in-retinal-periphery-closely-matches-loss-of-blood-flow-in-people-with-diabetes.html. Accessed Oct. 19, 2015.
2. Silva PS, Dela Cruz AJ, Ledesma MG, et al. Diabetic Retinopathy Severity and Peripheral Lesions Are Associated with Nonperfusion on Ultrawide Field Angiography. Ophthalmology. 2015 Sep 6. pii: S0161-6420(15)00773-3. doi: 10.1016/j.ophtha.2015.07.034. [Epub ahead of print].
Final rule on Stage 3 MU, Stage 2 changes
CMS brings some clarity, if not total satisfaction, to Meaningful Use.
By René Luthe, Senior Editor
When CMS recently issued the final rule for Stage 3 of Meaningful Use, as well as its Stage 2 modifications for 2015 through 2017, it was “far from a perfect solution,” says Michael X. Repka, MD, American Academy of Ophthalmology’s medical director of Government Affairs. But, he adds, they do offer some relief to participating physicians — for a while.
Here’s how it breaks down.
Stage 2 modifications
Physicians have a shorter reporting period for 2015 — 90 days. The problem, as others have noted, is that the countdown started Oct. 6, the day CMS announced the more flexible reporting period. But, the calendar year ends before the period runs out. Also, this shortened period is temporary; the 90-day requirement is only for 2015.
Stage 3 requirements are optional in 2017 and mandatory in 2018.
Providers who opt to begin Stage 3 in 2017 will have a 90-day reporting period.
More helpful …
• Online portal VDT measure is easier to satisfy. CMS changed the VDT (View, Download & Transmit) measure from 5% of patients to just one patient. But while medical IT consultant Daniel Patterson hails that move as a “much-needed change,” these portals will remain problematic for physicians, says Mr. Patterson, owner of Daniel L. Patterson Group, LLC.
While “attesting for use” is easier, CMS did not change the requirement for “attesting for access” that necessitates that 50% of patients must have the ability to view their data, download it in both human and machine readable formats, and electronically transmit their data. “That will be a tough thing for some practices,” he said. What would have been better, he adds, is if CMS had aligned the changes with the years when MU2 expires and MU3 takes effect, in 2017.
• No more clinical summaries. According to Mr. Patterson, “This is a huge deal” because practices will save money since they will no longer print these documents. He says a provider who sees 30 patients per day, per annum, would have 7,500 visits. If each visit cost $.06 per visit ($.02 a page, three pages per summary), “[That] is $450 per year of just wasted paper. One of my clients has approximately 25,000 patient visits per year so they’ll save $1500 per year on paper.”
• The number of reporting objectives are reduced. Eligible professionals (EPs) now have 10 of them, down from 18 objectives in prior stages. One of the 10 objectives, however, must be a public health reporting objective.
Eligible hospitals and critical access hospitals (CAHs) now have nine reporting objectives, down from 20 in prior MU stages. Clinical quality measures haven’t changed.
• The reporting period is moved to the calendar year instead of the fiscal year.
“Overall, I think these changes will make MU2 much easier to meet,” Mr. Patterson says.
Stage 3 final rule
Of the eight proposed reporting objectives for EPs, eligible hospitals and CAHs, more than 60% require interoperability, compared with 33% in Stage 2.
The medical community is disappointed with CMS’s finalization of Stage 3, the Academy says, as are congressional members. The only way to preserve the overall goals of the MU program was a “pause in the rulemaking,” according to an Academy press release. This pause would ensure that the goals line up with changes stemming from the Medicare Access and CHIP Reauthorization Act of 2015 and give everyone time to understand the impact of Stages 1 and 2.
“Postponement was the logical decision,” agrees Kevin J. Corcoran, COE, CPC, CPMA and president of Corcoran Consulting Group. “Stage 1 was moderately successful, and more than half of ophthalmologists signed up. Stage 2, since it imposed more requirements and raised the bar for Meaningful Use, resulted in ... fewer doctors attesting. Stage 3 is not ready for prime time.” He adds, “Since there is an election in 2016, we may see some significant changes to the HIT program. MU Stage 3 will probably be altered even more before it is initiated.”
AMD’s recurrence in Asian eyes linked to gender and age
By Robert Stoneback, Associate Editor
A recent Japanese study in older Asian men with age-related macular edema has found recurrence of retinal exudatives after follow-up treatments with ranibizumab (Lucentis, Genetech).1 But, the AAO says, such results are less likely in Western populations.
American physicians use a “treat and extend” or “fixed” retreatment schedule for AMD patients, as opposed to the method used by Asian doctors, says Abdhish Bhavsar, MD, clinical spokesperson for the AAO.
Asians usually have a higher proportion of polypoidal choroidal vasculopathy (PCV) as an AMD component; why is unknown, Dr. Bhavsar says, though it is likely genetics-based since PCV occurs more often in eastern populations than in western ones.
Also, many of the Asian patients studied had prior treatments with photodynamic therapy, which is used much less commonly in the United States due to the lower rate of PCV.
The study stated that older age and the male sex could predict recurrence of AMD after three monthly injections of ranibizumab. The study also noted that PCV-affected eyes experienced recurrence earlier.1
The study examined a total of 343 eyes in 326 Asian patients past the age of 50, with subfoveal neovascular AMD. This was treated with an as-needed regimen after three monthly loading doses of intravitreal ranibizumab.1
FDA approves Alcon’s UltraSert
The FDA granted approval of Alcon’s AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System, according to the company. The delivery system, designed for patients undergoing cataract surgery, was created to give the control of a manually loaded device combined with the benefits of a disposable injector. The delivery system also helps to create a less invasive corneal incision during cataract surgery, using a smaller nozzle tip that allows for an incision down to 2.2 mm, according to the company. Its depth guard nozzle prevents users from inserting it too deeply.
Alcon Surgical
236 eyes showed resolution of exudative charges after three loading injections. Of those, 81 eyes experienced no recurrence during the first year, and 139 eyes showed no recurrent exudation after two years.1
During the first year, older patients and male patients more frequently required treatment for recurrences, the study indicates. OM
REFERENCES
1. Factors Associated with Recurrence of Age-Related Macular Degeneration after Anti-Vascular Endothelial Growth Factor Treatment. Conducted by members of the Kyoto University Graduate School of Medicine and the Kagawa University Faculty of Medicine. Presented at the American Academy of Ophthalmology Annual Meeting, Oct. 2014. Accessed Oct. 12, 2015.
QUICK BITS
Omeros Corporation has launched OMIDRIAssure, a reimbursement services program to expand access to Omidria 1% / 0.3% for cataract surgery patients. It will also provide reimbursement assistance for physicians and facilities, among other services.
Avedro has resubmitted a new drug application to the FDA for riboflavin ophthalmic solution/KXL System, a therapeutic treatment for progressive keratoconus and corneal ectasia following refractive surgery. Avedro anticipates an application action date in April 2016.
European ophthalmology company URSAPHRAM and clinical stage specialty pharma company Novaliq announced a partnership agreement and the European launch of EvoTears. URSAPHARM obtains the exclusive license for EvoTears, Novaliq’s evaporative dry eye disease treatment.
Ophthalmic equipment provider Enhanced Medical Services, based in St. Louis, MO, has acquired Star Ophthalmic Instruments, based in the Midwest. This transaction marks the second acquisition made by EMS in the past 18 months.