Quick Hits

More accommodative IOLs in the pipeline

Akkolens and Power Vision present at OIS.

When cataract surgeons are asked what they would like to see in the next generation of premium IOLs, they almost universally respond that they want more and newer options in accommodative lenses. At the recent Ophthalmology Innovation Summit (OIS) in New Orleans, two investigational premium IOLs, the Lumina from Akkolens International (Breda, The Netherlands), and the Fluid Vision, from Power Vision (Belmont, Calif.), were introduced to the hundreds of attendees.

Currently, the only accommodating IOLs approved by the FDA for use in the United States are the Crystalens and Trulign Toric (both Bausch + Lomb, Rochester, N.Y.). Though first approved a decade ago, the Crystalens has been consistently improved and has proved itself in many thousands of US patients. Another investigational accommodative lens, the much-awaited dual-optic Synchrony (Abbott Medical Optics, Santa Ana, Calif.) has been in late-stage clinical trials in the United States for several years.

At OIS, Akkolens founder Michiel Rombach, PhD, MBA, explained that the Lumina is a dual-element accommodating lens implanted within the ciliary muscle with a 2.8-mm incision. The ciliary muscle drives the lens directly. The company states that the Lumina can provide 4 D of accommodative power.

The Lumina is now in 65 eyes in an ongoing clinical trial and Dr. Rombach reported that interim data has been excellent at near, intermediate and far distances. The company expects to apply for the CE mark in 2014.

With regard to the Fluid Vision accommodating IOL, company co-founder Barry Cheskin, MS, MBA, reported that the injectable lens is based on proprietary, fluid-controlled technology that in clinical trials has shown itself to be capable of delivering more than 5 D of “true” accommodation with excellent vision at all distances. The key to the wide range of accommodation the Fluid Vision provides is that the natural muscle movement of the eye moves the silicone fluid in the IOL to change the shape and thickness of the lens. The outer portion of the IOL that encases the fluid is made from a proprietary hydrophobic acrylic matched to the same refractive index as the fluid within.

Though many of the most promising premium IOLs are still in the US investigational pipeline, the future looks bright for a more robust premium channel in future years.

Successful practices take patient surveys

MGMA says feedback from patients helps improve care.

Taking the time and making the effort to listen to what your patients have to say about the care you provide can be a critical element in improving the performance of your practice, says the Medical Group Management Association (MGMA). Almost 80% of medical practices deemed “better performers” by the MGMA 2013 analysis of successful practices indicated they used patient-satisfaction surveys.

Compared with lower-rated practices, the MGMA reported that the better performers were more likely to assess patient satisfaction in their practice and did so more frequently.

Practices said they conducted satisfaction surveys to gauge, among other things, their patients’ overall experience, professionalism of the staff, availability of appointments and quality of care. More than half of better-performing medical practices indicated they used patient-satisfaction surveys to evaluate and improve practice operations and educate staff and physicians about behavior.

“Successful groups actively and regularly will solicit feedback from their patients,” said Kenneth T. Hertz, FACMPE, of the MGMA Health Care Consulting Group. “Patient satisfaction surveys give practices an immense amount of detail on their patients’ experience, and that feedback is particularly useful as medical groups seek to improve and elevate the care they provide.”

Almost 10% of better-performing practices cited using patient-satisfaction survey results as “part of physician compensation formula.” The MGMA said its most recent physician compensation survey (June 2013) indicated that quality and patient-satisfaction measures now appear to be a small but emerging factor in determining total compensation for physicians.

FDA moves forward to prevent drug shortages in the future

Plan outlines concrete measures.

By René Luthe, Senior Associate Editor

Continuing its effort to prevent drug shortages such as the epinephrine and Wydase shortages that have roiled the ophthalmic community in recent years, the FDA recently released a strategic plan and a proposed rule that would extend its early notification requirement for potential supply disruptions.

The new plan and proposed rule are in response to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) that called for the FDA to improve its response to drug shortages and address their causes. The act also empowers the FDA to mandate that drug manufacturers notify the agency as soon as possible upon becoming aware that production of a “life-supporting” or “life-sustaining” drug would be interrupted, and at least six months’ notice if such a drug would be discontinued.

The new proposed rule would extend the notification requirement to include makers of biologic drugs as well. As for the strategic plan, one component aims to improve the FDA’s coordination and communication about drug shortages, including launching a mobile smartphone application to provide real-time shortages information, and reviewing interactions between the groups within the FDA that handle shortages.

Other measures include identifying incentives the FDA can offer manufacturers for improving production and quality, and for steps to end or prevent a drug shortage; developing ways to identify early warning signals of potential shortages; and suggestions for manufacturers that would help prevent shortages.

“Now we’re in the implementation phase of the FDASIA law,” says Erin Fox, PharmD, director of University of Utah’s Drug Information Service. “One of the things I’m most encouraged by is the FDA’s goal of working on long-term prevention strategies. That’s something we haven’t seen in past plans and we really need that to explore incentives for manufacturers to have high-quality manufacturing. I think that is probably the measure that will help the most in preventing drug shortages in the long run.”

The FDA reports that since FDASIA was passed, the agency has seen a sixfold increase in notifications about potential shortages.

Regarding the ongoing shortage of non-preserved epinephrine that has plagued ophthalmologists, Ms. Fox notes that there is good news and bad news. Physicians do have access to an FDA-approved, ophthalmic-indicated epinephrine product; however, some do not like the sulfite it contains. “That sulfite-free, preservative-free presentation of epinephrine that some ophthalmologists really want, we don’t have an estimated release date for that yet,” she says.

Femtosecond laser excels with challenging cataracts

Managing zonulopathy, pediatric cases and dense cataracts.

By Mark Packer, MD

Capsulorhexis in the setting of zonulopathy can challenge even skilled surgeons. Ectopia lentis, Marfan’s syndrome, even severe pseudoexfoliation can pose difficulties because absent or weak zonular fibers do not provide the requisite counter traction when attempting to pierce and tear the anterior capsule. The resulting irregular, small or torn-out capsulorhexis may then lead to further difficulties in lens extraction and IOL fixation. However, given a clear cornea and adequate pupil dilation, the femtosecond laser can create a round, centered and appropriately sized capsulotomy irrespective of zonular insufficiency.

Pediatric cataract surgery poses many special considerations, not the least of which is the highly elastic anterior capsule and the risk of a runaway capsulorhexis. Femtosecond laser anterior capsulotomy avoids this risk, and also provides the capability (in those models with a liquid interface) to re-dock the eye following IOL implantation and construct a posterior capsulotomy as well.

Dense, brunescent cataracts can pose difficulties for phacoemulsification because their leathery consistency resists chopping and their voluminous size, with absent epinuclear and cortical layers, resists rotation. Femtosecond laser phacofragmentation can aid in these cases by effectively pre-chopping the nucleus, including the tough posterior plate, facilitating their phacoaspiration.

Accurate imaging and guidance are crucial so the laser pulses can be placed within 500 μm of the posterior capsule.

Dr. Packer is president of Mark Packer MD Consulting in West Palm Beach, Fla. He is a consultant to LensAR Inc.