Surgery

Cataract surgery: Going dropless

How a single injection may redefine roles for the ophthalmic staff.

By Bill Kekevian, Senior Associate Editor

Tracy Insalaco COA, lead ophthalmic technician, prepares a preoperative test.

Technician COA, Tracy Insalaco, is exuberant now that two transzonular injections, delivered during cataract surgery, are gaining popularity among ophthalmologists. Her practice, Eye Care Northwest in Sparta, NJ, represents the home turf of the new formulations of these drugs, which may eliminate the need for cataract patients to self-administer eye drops. Eye Care Northwest’s surgeon, Jeffrey Liegner, MD, developed the injection in partnership with Imprimis Pharmaceuticals. He has performed more than 4,500 of what they’re calling “dropless” cataract surgeries to date.

“Dr. Liegner had been working for years on developing this idea. After years of watching the price of eye drops climb to exorbitant levels he thought, ‘There has to be something out there that we can put inside the eye as medicine during the procedure that can be more affordable for patients,” Ms. Insalaco explains. “It really is exciting to be part of this.”

With the injections, cataract patients no longer need to bear the burden and associated costs of instilling antibiotic, anti-inflammatory, or steroid eye drop medications. Taking this step out of the process has led to a chain reaction that’s redefining roles for the entire support staff.

With drops, Ms. Insalaco says, “you always worry about the idea of the patient abrading their eyes or contaminating the bottle. You wonder ‘did I teach them right? Are they delivering the drops properly?’”

Without drops, the risks of patient non-compliance, confusion over drop schedules, redundant patient drop education, time spent contacting pharmacies for refills, and patient complaints about costs are all eliminated.

“It’s a huge peace of mind knowing that’s all behind us,” she says.

The science

Dropless and limited-drop approaches to cataract surgery have been around for some time. The two new injections developed by Imprimis are proprietary compounded formulations: TriMoxi (the corticosteroid triamcinolone acetonide plus moxifloxacin hydrochloride, an antibacterial) and TriMoxiVanc (which adds vancomycin, an antibiotic). In a retrospective study that ran from 2006 to 2013, 2,300 eyes receiving the injections were evaluated. The results showed no cases of endophthalmitis and 98% remained free from CME and inflammation.

James S. Lewis, MD evaluated 200 cataract procedures in 129 patients without pre-existing macular pathology. In 5% of cases, he added a short course of topical steroid. The investigation resulted in a CME rate of 2% when transzonular triamcinolone was used in place of topical anti-inflammatory medications. In his presentation, he noted that current literature reports that CME rates are between 0% and 8% after uncomplicated cataract surgery using post-operative topical steroids and NSAIDs.

Both studies were led by investigators who are consultants for Imprimis.

Patient expectations

Cynthia Matossian, MD, of Matossian Eye Associates, a multi-location practice in New Jersey and Pennsylvania, mentions several reasons why she will implement the injection procedure. “Patient expectations are now so high that even if we do our best as surgeons, the one thing we have no control over is what patients do with the medications they are asked to use postoperatively,” she says. To wit, a 2005 study on compliance following cataract surgery used a microprocessor to monitor eye drop use. The study looked at 20 patients, all of whom were non-compliant with regard either to total dose, time intervals or premature discontinuation of therapy.¹ The study’s findings do not surprise Dr. Matossian or her staff. “Most people don’t adhere to the regimen we recommend,” according to Dr. Matossian.

Stacy Stapert works the front desk at Eye Care Northwest in Sparta, NJ.

Confusion

For Sue Henry, COO at Loden Vision Centers, a six-location practice in Tennessee, watching patients, many of whom struggle with memory loss, trying to adhere to drop schedules was an emotional experience. Some patients were lucky enough to have family members take care of them, but for many, it became part of the patient’s regular routine to show up at the office and ask for assistance. “It’s heart-wrenching,” she says. “You want to do as much as you can for them. We’ve always been happy to help, but our staff was running out to the waiting area every few hours or during lunch to help patients with their drops.” To add to that, she says, “we probably spent more time on phone calls from patients confused about how to use drops than the patients coming into the office for further instructions.”

Kruti Shah, OD, Tracy Insalaco COA, and Jeffrey Liegner MD.

Dr. Matossian can empathize. “I can’t underscore how inundated we are with phone calls. It is creating havoc for our staff to deal with the incoming calls regarding perioperative eye drops. It’s unproductive time. Moreover, it upsets patients because there’s so much confusion about branded drug coverage (or lack thereof) by their insurance carriers,” she says.

Although Loden Vision Centers has only begun applying dropless cataract surgery, Ms. Henry says those phone calls and unscheduled office visits have dwindled to nearly nothing. “The only phone calls our nurses are getting now are for glaucoma medication refills,” she says.

Special needs

Because cataract patients are primarily in the 65 or older age range, they are often battling multiple comorbidities. Some of these, such as arthritis and Parkinson’s disease, create drop instillation issues. Others, such as Alzheimer’s disease, carry cognition issues. Recent clinical trial information shows that improved vision from cataract surgery can, in fact, increase cognition in patients suffering from dementia.² For these patients, cataract surgery may not have been an option because of their inability to follow a strict drop schedule. “For some of these drops, they’re so regimented, some patients feel as if they’re housebound for a month,” says Ms. Insalaco. For patients with these special needs, she adds, those limitations could be enough for them to avoid the surgery altogether, ultimately leading to reduced visual acuity and a decrease in quality-of-life.

Other dropless and limited-drop approaches

Some doctors, such as Larry Patterson, MD, of Eye Centers of Tennessee, have used an intraoperative injection approach for years. Dr. Patterson no longer uses transzonular injections. In his experience, and that of several doctors he’s communicated with, a small, but significant percentage of “totally dropless patients” developed late postoperative iritis that can cause substantial problems. Although he didn’t use the Imprimis formulation, his practice opts for a different approach; one that employs an antibiotic-steroid injection into the anterior chamber, pioneered by James Gills, MD. “It’s a solution, not a suspension so you don’t have all those particles that obstruct people’s vision,” he says. “We just inject a little bit of it into the wound and the rest of it into the anterior chamber. But the next day we do start them on steroid drops,” he says. “So, it’s not totally dropless. But we haven’t used postoperative antibiotic drops for several years now. We still don’t have all the problems we had before with people calling and all these issues.”

Generics

One of these patient issues involves generic drugs, says Ms. Henry. “Traditionally, we would start drops three days prior to surgery,” she says. “We had a lot of callbacks. Patients would complain ‘my insurance doesn’t cover this.’ ‘Can I have a generic?’ ‘Is it absolutely necessary I use it four times a day?”

Although patients sometimes attempt to ease the financial burden by seeking out generics, Dr. Matossian says, that comes with its own set of complications. “In some cases, these generics are dramatically different. Say we prescribe a branded drug, which has a once-a-day indication; instead the patient ends up with a generic, which has to be used four times a day,” she says. The patient may get the directions confused and end up using the generic product according to the branded instruction of once a day. “There’s a lot of room for error and potential under treatment,” Dr. Matossian says.

Eye Care Team at Eye Care Northwest: Back Row left to right: Josephine Amato, Elaine Lombardi, Heather Barbato; Middle Row: Stacey Stapert, Kristina Swyryt, Carla Forte, Carla Meyer; Front Row: Tracy Insalaco.

Patient care

Since it brings with it a reduction in phone calls, drop schedules and patient drop education, the injections are “putting the work force back to work at the job of patient care,” says Ms. Henry. “Technicians and nurses are going to be able to spend more time educating the patient on ophthalmic care rather than dealing with paperwork and drop schedules.”

Ophthalmic staff can now spend more time educating patients on IOL options, according to Ms. Insalaco.

With these injections, practices need to educate patients preoperatively to set expectations, Ms. Insalaco says. “Because of the volume of the medication we inject, the patient will see a large dark circle in the eye postoperatively and, as the medicine starts to absorb, it breaks up into smaller pieces and the patient perceives this similar to floaters. Their immediate reaction may be to be nervous, but we spend time preoperatively educating them about what to expect so they are completely aware and know what this is.”

Reactions

Often, Eye Care Northwest will see cataract patients seeking a second opinion, perhaps because the phrase “dropless cataract surgery” has peaked their interest, Ms. Insalaco says. “These patients were handed scripts for drops and billed $400,” she says. When they’re told that they won’t have to put out that much money or spend time applying eye drops, “It’s jaw-dropping to them. I would say for some of our patients, it’s a deciding factor. It’s a major change for us as well. Patients say ‘now that I know I’m not going to need to use eye drops, my kids aren’t going to have to come and see me three times a day to put my drops in. Sign me up.” OP

Kruti Shah, OD, chats with Tracy Insalaco at Eye Care Northwest in Sparta, NJ.

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