Point-Counter Point

Use triamcinolone injections: here’s why

By Pit Gills, MD

Our goal as cataract surgeons is to optimize outcomes while minimizing risk and cost. A major variable in that equation is postoperative inflammation management. Over the past 15 years, minimizing or eliminating the postop drop regimen has gained significant interest. We can approach this issue many ways, but the goal should remain the same: choose the most effective method with the least amount of risk.

We should establish the following four major criteria as universally important goals when evaluating intraoperative and postoperative medication regimens.

• Minimize the cost burden to the practice and patient.

• Maximize patient compliance.

• Meet our safety standards and minimize risk to the patient.

• Don’t compromise the “wow” effect at 24 hours postop.

Since we began using triamcinolone at St. Luke’s in 2003, we continuously measure our technique against these criteria, which has evolved significantly over the past decade.

Finding our way

In 2003, after investigating the effectiveness of triamcinolone with macular edema, we began using triamcinolone injections off label for our cataract patients. Our first approach was to inject it directly into the anterior chamber; eventually, we changed to a transzonular injection. We made this change so the medication would last longer. With both techniques, we dramatically reduced the need for postoperative steroids and NSAID drops, but the triamcinolone temporarily clouded vision and compromised the “wow” effect.

In 2004, we changed our technique to a sub-Tenon’s injection. This technique seems to deliver a better balance of preserving the “wow” effect while providing a sustained delivery of steroid. For patients who receive the sub-Tenon’s injection, the need for postoperative drops is minimal: we prescribe antibiotic QID for two days and NSAID QD for six weeks. Our simple drop protocol makes for a high level of compliance.¹

Sub-Tenon’s injection of triamcinolone is also an affordable option, costing the practice approximately $1.50 per patient. It dramatically decreases our patients’ need for postoperative drops, which enhances patient satisfaction and compliance. Finally, a sub-Tenon’s injection does not compromise our patients’ acuities.²

An eye on risk

We continue to be vigilant about our attention to the risk variable of the equation, even though the risk is low overall. Since 2004, I have performed more than 25,000 sub-Tenon’s injections, and have never experienced a case of endophthalmitis or perforated a globe. The risk of sub-Tenon’s triamcinolone is subtler. During the first six weeks postop, our greatest concern is an undetected pressure spike postoperatively, or intractable pressure.

Because we want to be extremely cautious and mitigate risk, we focus on three areas:

» Patient selection. We have a strict selection protocol and use a traditional postoperative drop regimen for those with a history of glaucoma, elevated IOP, steroid response or who are glaucoma suspects for any reason. Clopidogrel (Plavix, Bristol-Myers Squibb) and aspirin are also contraindications. Our concern with these medications is the potential risk of a vision-threatening retrobulbar hemorrhage, and to a lesser degree, the cosmetic impact of a subconjunctival hemorrhage. We have tightened our selection process over the years in an effort to eliminate patients who could be at risk for a pressure spike postoperatively, such as those listed above. Today, we administer triamcinolone in fewer than 60% of our cataract cases.

» Placement of the injection. Exact placement of the triamcinolone is critically important. In our history of 25,000 sub-Tenon’s injections, we have cut out the triamcinolone three times because of intractable pressure. In each of these three cases, we inadvertently placed the medication subconjunctivally rather than sub-Tenon’s. It is our experience based on thousands of cases that when the triamcinolone has been placed in the sub-Tenon’s space, we have found that intractable pressure is rare. So, risk has to be balanced. A conservative approach reduces the risk of perforation, but it’s more likely that the medication will be placed in a subconjunctival manner and it’s possible that intractable pressure will occur. On the other hand, ensuring sub-Tenon’s placement could potentially increase the risk of perforation.

» Strong communication with follow-up physicians. Our greatest concern with triamcinolone is an undiagnosed pressure spike. We have a strong referral network who participate in the postoperative follow-up care of our patients. We have worked hard to ensure that we educate them on our technique so they understand the potential risks and perform consistent follow-up with our patients. We count on their strong communication and their ability to detect pressure spikes.

Conclusion

We have come a long way in a short time in managing postoperative inflammation, but the perfect solution that is ideal for every surgeon and patient still eludes us. Using triamcinolone with cataract surgery gives us one more option in our arsenal.

Safety, efficacy and risk have always been top of mind when taking care of our patients, but cost has become an increasingly overarching theme to practicing medicine. When considering treatments, we have to think beyond cost to the patient and practice. Our decisions in patient management have great implications with government payment programs and how we rate as physicians, affecting our reimbursements from Medicare and private insurance. Our challenge as an ophthalmic community will be to address this creatively — without losing sight of giving patients our best. OM

REFERENCES

About the Author
	Pit Gills, MD, specializes in cataract, LASIK and other refractive surgeries. He practices at St. Luke’s Cataract & Laser Institute, Tarpon Springs, Fla. Contact him at 855-837-2020.

Use topical antibiotic drops: here’s why

By Steven M. Silverstein, MD

Despite the national and international trials attempting to make an explicit case for the use of prophylactic antibiotics to substantially lower the incidence of endophthalmitis, the jury is still out. While specific outcome measures for intracameral antibiotics are encouraging, the data are insufficiently conclusive to establish consensus. Regardless of the antibiotic employed or its method of delivery, rates of endophthalmitis, though low, remain remarkably varied.

Evidence: What’s the hold-up?

Statistical significance has not been established due to many variables. Most important, the “N” required to power such a prospective trial is tremendous. Secondary variables include: single vs. multiple surgeons, surgeon experience, antibiotics selected, method of drug delivery, nuances in surgical protocol/experience and role of operating room staff — not simply from OR to OR, but from country to country.

Further, even when limiting surgical technique to small-incision phacoemulsification (rather than extracapsular cataract extraction), exposure time, ancillary products used (i.e., branded vs. compounded agents, and so on), wound size and closure technique (sutured vs. sutureless or glued incision) and patient demographics only add to the difficulty in standardization. That said, most studies share some calculated degree of difference among clinical sites, and yet, definitive judgment regarding proper prophylaxis against infectious pathogens remains greatly debated.

Drug delivery

The purpose of this exercise is not to consider which class or generation of antibiotics is employed, nor whether antibiosis is even necessary, but rather, which method of drug delivery might be most efficacious.

No peer-reviewed study conclusively proves that antibiotic use in the perioperative arena clearly lowers the incidence of endophthalmitis. Their use for this purpose is frankly off-label yet also remains the standard of care. During my cornea and external disease fellowship in 1990, I learned that a professor I greatly admired did not use antibiotics in any form, including for transplant patients, because of the lack of compelling data to support the use of perioperative antibiotics. His data in prior years showed no increase in endophthalmitis compared to accepted national statistics, and we saw no cases of endophthalmitis during my year of training.

Antibiotics and us

Despite mixed reviews in the literature, antibiotic use in some form remains the standard of care. To be effective, an antibiotic must reach its target tissue and remain at its minimum inhibitory concentration necessary to eradicate at least 90% of the test organism (MIC90) levels for a sustained period of time. Whether we inject antibiotics into the eye (AC or vitreous) or deliver them via subconjunctival or sub-Tenon’s injection, their duration of action (or ability to maintain an effective MIC90) for more than a few days is suspect at best.

However, topical antibiotic drops can provide a sustained therapeutic MIC90 level as measured by aqueous tap. Most cases of endophthalmitis present between day four and day seven postop. Considering that we cannot control the hygiene of our patients as they rub their irritated postoperative eyes, though as commonly mentioned, I may be treating myself more than the patient, I believe that keeping the postoperative eye bathing in an antibiotic-rich milieu during the first 2+ weeks of wound healing is ideal.

Intracameral antibiotics work

Four large studies show endophthalmitis risk is reduced with this method of delivery

By Larry E. Patterson, MD

Estimates of cataract surgery numbers in the US are hard to pin down, but let’s say it’s about three million per year. As prices for postop medicines have skyrocketed out of proportion for myriad reasons, and drug insurance coverage is spotty at best, many patients are having a difficult time finding ways to pay for those prescribed drops.

In 2013 I wrote about attempts to go “dropless”, or at least to use fewer drops.¹ Many surgeons, including myself, have been using intracameral antibiotics for years, and now are foregoing topical antibiotics entirely. I noted in that editorial that Jim Gills has performed about 75,000 cases this way for more than 15 years without a single case of endophthalmitis. I am only at 4,000 cases without instilling routine postop antibiotics, but my results are the same: no infections. And note, I am simply talking about injections into the anterior chamber, not intravitreal, although that’s another option.

Call out the howitzers

Now for the big guns. The journal Ophthalmology published three large studies from three countries (including the United States) involving more than 600,000 patients.^2-4 That’s big data. Researchers found at least two things. First, when surgeons added intracameral antibiotics, there was anywhere from a two- to four-fold reduction in endophthalmitis. Secondly, if the surgeon was already using intracameral antibiotics, the addition of topical antibiotics did nothing.

And in March, French ophthalmologists wrote in Ophthalmology about the incidence of acute postoperative endophthalmitis (POE) after cataract surgery with phacoemulsification between 2005 and 2014.⁵ Using a national database, they looked for these cases, along with the use of intracameral antibiotic injection. The numbers: 6 million plus eyes had the surgery. The incidence of acute POE, identified at six weeks, decreased from 0.145% to 0.053% during the study time span, as the use of intracameral antibiotics increased.

Obstacles exist. For now there is no commercially available FDA-approved product specifically for this indication. Possible solutions include injecting brand name unpreserved drops; having your center or local pharmacist (as I do) compound them; or ordering them from a compounding pharmacy. But that could impose a small but real medico-legal risk to us. Additionally, who pays for this? For now, we do. But hopefully in the future either the patient or the third-party payer will pay for this.

The AAO already has a position paper that’s been endorsed by retinal specialists saying that postop drops are unnecessary after intravitreal injections; now hardly any of these specialists use them. It’s time for the AAO to do the same on the non-use of topical antibiotic drops after routine cataract surgery. It could help take a bite out of the legal risk, and might start a dialogue with payers about increasing the reimbursement to cover it. OM

REFERENCES

1. Patterson, L. To drop or not to drop? Ophthalmology Management. 2013;July:17;4. http://tinyurl.com/h24o3t6.

2. Javitt JC. Intracameral antibiotics reduce the risk of endophthalmitis after cataract surgery: Does the preponderance of the evidence mandate a global change in practice? Ophthalmology. 2016;Feb: 2; 226–231.

3. Herrinton LJ, Shorstein NH, Paschal JF. Comparative effectiveness of antibiotic prophylaxis in cataract surgery. Ophthalmology. 2016; Feb:2; 287-294.

4. Jabbarvand M, Hashemian H, Khodaparast M. Endophthalmitis occurring after cataract surgery: Outcomes of more than 480 000 cataract surgeries, epidemiologic features, and risk factors. Ophthalmology. Published online Dec. 16, 2015. http://tinyurl.com/zsssu9g.

5. Creuzot-Garcher C, Benzenine E, Mariet AS, et al. Incidence of acute postoperative endophthalmitis after cataract surgery: A nationwide study in France from 2005 to 2014. Ophthalmology. 2016; Mar:16. http://www.ncbi.nlm.nih.gov/pubmed/26992840.

Larry E. Patterson, MD, is the Chief Medical Editor for Ophthalmology Management and medical director of Eye Centers of Tennessee in Crossville. He can be reached at larryp@ecotn.com.

Considering the anti-inflammatory approach

While the arguments about study designs and variables stated above also apply to our understanding of methods of drug delivery for steroids and NSAIDs, the literature and anecdotal experience is much more robust and compelling regarding the importance of perioperative anti-inflammatory medicines. In this arena, efficacy is measured in terms of the medicine’s IC50 — how much anti-inflammatory medication is required to inhibit at least 50% of the target enzyme (i.e., phospholipase A2, cyclooxygenase, and so on). We know from pharmacokinetic and concentration data that potency and efficacy of these medicines are relatively short-lived. Periocular and intraocular injections of these medicines (except sustained-release medications specifically designed to treat disease states such as recalcitrant uveitis or chronic DME) are unavailable at therapeutic levels after several days. Even though current surgical technique obviates the need for intermediate-term anti-inflammatory therapy because it is gentler and promotes significantly less inflammation, the use of these medications remains universal. We have all seen patients, regardless of the drug delivery method, who have experienced prolonged or rebound inflammation and its sequelae, who usually require either another round of anti-inflammatory treatment, a stronger medication than the standard protocol, or both.

Our best opportunity to avoid the unwanted manifestations of inflammation is to hit it in an aggressive and sustained manner from the beginning. My involvement in clinical research and understanding of the inflammatory cascade has made me a strong believer in the concurrent use of both a strong steroid as well as a potent NSAID. Since we cannot predict which patients may have more difficulty controlling the inflammation, (especially in African-American and Hispanic populations), I instruct them to use the entire bottle of medication until it is empty.

Final thoughts

I deliberately did not discuss the issue of treatment cost to either the third-party payer or to the patient. Obviously, this is a key component of this ongoing discussion. Rather, I limited my comments, as I do in my clinical practice, to the science and what I believe is in the patient’s best interest based upon our didactic discussions, properly designed and controlled clinical trials, and my experience with tens of thousands of surgeries.

In the end, I always ask myself, “What would I do for my own eyes”? OM

About the Author
	Steven M. Silverstein, MD, FACS, is a cornea-trained comprehensive ophthalmologist in practice at Silverstein Eye Centers in Kansas City, Mo. His e-mail is ssilverstein@silversteineyecenters.com.