Guidance on Ongoing Port Strike, Hurricane Helene Aftermath
Organizations are offering guidance to surgical facilities that might experience supply chain disruptions from the port workers’ strike and the aftermath of Hurricane Helene....
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By: Daniel Cook
Published: 4/8/2021
Cataract surgery used to be a straightforward procedure. In a matter of minutes, surgeons eliminated a patient's blurred or clouded vision by replacing the eye's natural lens with a standard IOL. Most patients were thrilled just to see clearly again.
That's no longer the case. "Every patient now seems to know a friend or family member who has 20/20 vision after surgery without having to wear glasses," says Ralph Chu, MD, the CEO of the Chu Vision Institute in Bloomington, Minn. "It's become a big motivator for patients. They come into my clinic and say, 'I want that, too.'"
Recent advances in extended depth of focus and trifocal IOLs, the interconnectivity of pre-op diagnostic devices with femtosecond laser platforms and new ways to administer intraocular medications that prevent post-op complications have ratcheted up the pressure on surgeons. They're constantly striving for more exact refractive outcomes to satisfy patients who show up for surgery with clear expectations of how clearly they want to see afterward.
"Our techniques and technologies weren't always good enough to stay ahead of the aging process and talk to patients about turning back the clock on vision quality," says Dr. Chu. "We're now getting to the point where we can start to have those conversations."
T. Hunter Newsom, MD, of Newsom Eye and Laser Center in Tampa, was involved in the FDA trials of RxSight's Light Adjustable Lens (LAL), which lets surgeons make small adjustments to the power of the implanted lens through a series of UV light treatments performed over several weeks after surgery. Surgeons are able to dial in post-op refraction to within a quarter diopter of the pre-op goal, essentially letting them customize the vision of patients with astigmatism.
Dr. Newsom recently compiled data from 86 patients who received the lens in both eyes, and the results are impressive: 80% of the patients saw 20/20 or better at distance and were able to read without glasses. "That's double the accuracy of refraction of other leading IOLs," says Dr. Newsom. "It's the most accurate lens I've used."
The non-diffractive extended depth of focus of Alcon's IQ Vivity, which was launched in January and is available in spherical and toric designs, stretches and shifts light instead of splitting it. Dr. Newsom says the lens matches the excellent distance vision of a standard toric IOL without the rings and halos associated with multifocal lenses that can impede nighttime vision. The Vivity also provides patients with some near vision, which can't be achieved with toric or standard IOLs. "The Vivity ultimately provides patients with great distance vision, good nighttime vision with no rings or halos and some near vision — which is a bonus," says Dr. Newsom.
In February, the FDA approved Johnson & Johnson's TECNIS Eyhance and TECNIS Eyhance Toric II lenses for implantation during cataract surgery. Both monofocal IOLs feature refractive surfaces and unique shapes designed to extend depth of focus and provide better image contrast in low light. "The lenses have been designed to be 'stickier' in the capsular bag, meaning they're more stable and less likely to rotate off the intended axis," says Dr. Newsom. "That's key for achieving improved refractive outcomes, especially with toric lenses."
Femtosecond laser assisted cataract surgery isn't new, but some fairly recent upgrades to the laser systems are helping surgeons achieve improved refractive outcomes more efficiently and with less reliance on intraoperative aberrometry for exact IOL alignment. New astigmatism management software available for Johnson & Johnson Vision's Catalys laser lets surgeons input pre-op keratometry and steep axis values, and automatically generates incision parameters in the platform's surgical planning software.
Surgeons can now use the Lensar system to make micro radial incisions in the capsular bag based on the patient's pre-op diagnostic measurements — which are uploaded directly to the laser from topography and anterior segment imaging devices — and use the markings to align toric IOLs more precisely during implantation for better management of astigmatism. During follow-up exams, surgeons can immediately notice if the lens is not perfectly aligned with the pre-op markings. "Surgeons no longer have to make the incisions by hand and the laser makes the notches based on pre-op topography data," explains Dr. Newsom. "That's a nice benefit."
Dr. Chu — who was one of the first adopters of femtosecond laser assisted cataract surgery — says the technology is a great option for making a consistent and perfectly shaped capsulorhexis, especially in denser cataracts that are difficult to visualize. He believes the laser has evolved into an essential tool for breaking up dense cataracts before using phacomulsification to extract the fragments. He also hints at new developments in the pipeline that will make femtosecond platforms more user-friendly and easier to integrate into the continued evolution of cataract surgery.
Injections and sustained release formulations of intraocular steroids and a medication that helps maintain pupil dilation during surgery hold promise for helping surgeons perform better surgery and reducing the burden of drop regimens that prevent post-op complications.
Omidria from Omeros, a phenylephrine and ketorolac irrigating solution administered through balanced salt solution during surgery, is FDA approved to maintain intraoperative pupillary dilation and is said to reduce post-op pain in patients. The drug's pass-through status — CMS pays facilities about $500 per case for its use — has been extended through 2021. Although surgical facilities receive separate reimbursement for the costly but effective medication, some surgeons still opt to use mechanical devices to manage miosis, especially in patients with floppy iris syndrome. For example, Dr. Chu often reaches for the XpandNT from Diamatrix, a device that holds pupils wide open to provide him with unimpeded access to the anterior chamber. "It's available in single- and multi-use versions, giving facilities the ability to purchase the most cost-effective option," he says.
Dexycu, a dexamethasone suspension in a biodegradable sustained-release aqueous sphere, is placed in the posterior chamber at the end of surgery to prevent post-op inflammation. Surgeons also have the option to use the intracanalicular implant Dextenza, which is inserted into the inferior punctum and remains in place for up to 30 days to deliver a tapering dose of dexamethasone.
Both drugs are FDA approved to prevent post-op inflammation and pain. The FDA's approval perhaps gives surgeons and patients more confidence in their use than compounded drop therapies available at a much lower cost. CMS reimburses facilities for the use of Dexycu and Dextenza separate from the standard cataract surgery fee, but some surgeons can't justify billing Medicare hundreds of dollars per case in a high-volume specialty when less costly alternative medications are available.
Dr. Newsom understands the allure of using FDA-approved medications to maintain intraoperative mydriasis or prevent post-op complications, but believes their use should be limited and determined on a case-by-case basis. "For example, placing dexamethasone into the eye at the end of surgery might make sense for Medicare patients who will have difficulty complying with a post-op drop regimen," he explains. "I'd feel more comfortable spending the money on patients who wouldn't administer the steroidal drops that prevent serious complications."
For now, Dr. Chu is sticking with prescribing his patients post-op topical antibiotic and steroidal drops, or both medications in combination drops, partly because Dexycu and Dextenza only eliminate the need for the steroid topical treatment. "If injections or plugs are developed that contain a nonsteroidal and an antibiotic, and they're shown to be effective, we might make the switch," says Dr. Chu.
Sublingual sedation is also a developing trend. MKO Melt from Imprimis is a tab containing midazolam, ketamine and ondansetron that's placed under a patient's tongue before their procedures. "It's been an invaluable tool in our clinic," says Dr. Chu. For several years, Dr. Chu used the tablets in place of IV sedation, a move that satisfied patients, who he says sometimes fear the stick of the IV start more than the surgery itself. Over time, however, Dr. Chu found patient flow at his busy surgery center was more conducive to the faster onset of IV sedation. (The MKO Melt, which is ingested though the digestive system, typically takes effect in 15 to 20 minutes, according to Dr. Chu.) "We've gone back to placing a small hep-lock in patients to administer IV anesthetic, but the tablets are extremely helpful for calming patients who are overly anxious before surgery," says Dr. Chu. "They definitely still have a place in our practice in augmenting IV anesthesia."
The ultimate goal of cataract surgery is to achieve the best possible refractive outcome, points out Dr. Chu. "That's done by treating small amounts of astigmatism, and doing so accurately," he says. "The more accurate we are in the treatment of astigmatism, the better the refractive outcome."
Dr. Chu believes technology presents plenty of opportunities to improve cataract surgery, but also several challenges. "Surgeons are faced with numerous new options and must decide which make the most sense for their practice," he explains. "That involves honest assessments of the clinical benefits that the platforms, tools and medications provide, understanding how to integrate them into established surgical routines and deciding if they can improve outcomes for more demanding patients." OSM
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