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Safety and efficacy of intravitreal injection of steroid and antibiotics in the setting of cataract surgery and trabecular microbypass stent

Kindle, Trevor MD*; Ferguson, Tanner BS; Ibach, Mitch OD; Greenwood, Michael MD; Schweitzer, Justin OD; Swan, Russell MD; Sudhagoni, Ramu G. PhD; Berdahl, John P. MD

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Journal of Cataract & Refractive Surgery: January 2018 - Volume 44 - Issue 1 - p 56-62
doi: 10.1016/j.jcrs.2017.10.040
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Abstract

Cataract surgery is 1 of the most commonly performed surgeries worldwide.1 With the aging population, this number will only continue to rise.2 As a consequence, new tools and techniques are frequently being introduced in efforts to obtain better outcomes and improve the safety and efficacy of the procedure. Although complications are not particularly common, the complications that can result are serious and have sight-threatening potential.3

Ophthalmologists use chemoprophylaxis to prevent potential complications. Cystoid macular edema (CME) is the most common cause of decreased vision after cataract surgery.4 Combinations of steroids and nonsteroidal antiinflammatory drugs (NSAIDs) have been shown to be appropriate prophylactic and definitive treatment regimens for CME.5 Inflammation and pain are also potential complications, and these can be prevented or treated similarly using steroids and NSAIDs.6,7 Endophthalmitis is likely the most feared complication of cataract surgery because of its sight-threatening potential. Although the overall incidence is less than 0.1%, clinicians remain motivated to minimize its occurrence.8 Povidone–iodine surgical preparations and antibiotics (perioperative and postoperative) are typically used as preventative measures against infection.

Although the actual drug classes used to prevent CME, inflammation, pain, and endophthalmitis after cataract surgery are generally agreed upon, the practice patterns for administration of these medications vary widely. In the United States, topical administration remains the most common practice. Topical NSAIDs lower the risk for CME and help treat postoperative pain and/or inflammation.7 Similarly, topical steroids are effective at reducing postoperative pain and inflammation.9 In the U.S., the perioperative use of topical antibiotics remains the most common method of endophthalmitis prevention.10

For various reasons, the use of topical medications, in particular antibiotics, has been debated in recent years. Surgeons have questioned the efficacy of topical antibiotics as a means of endophthalmitis prophylaxis, whereas others have suggested that simply using perioperative povidone–iodine alone is equally effective at preventing endophthalmitis.11,12 Furthermore, eyedrops can irritate the cornea and regimens are often complicated and burdensome to patients, which contributes to poor compliance.13–15 In addition, the drops are typically expensive, and 1 study that evaluated patient compliance in cataract surgery14 found that patients only used one half of the prescribed number of drops as part of their regimen. Ultimately, these challenges and data suggest that compliance is a legitimate concern and can contribute to poor outcomes and complications for patients.

Thus, surgeons have been evaluating and pursuing drug-delivery alternatives to topical medications. In European countries such as Sweden, intracameral antibiotics are used almost exclusively and have been shown to be efficacious.16,17 Similarly, the use of intracameral triamcinolone to reduce postoperative inflammation has been studied.15 Although it is encouraging that surgeons have been able to safely and effectively use medications inside the eye, barriers remain that might slow adoption. In the U.S., intracameral antibiotics are not available in a compounded form.18 Other concerns include reports of delayed adverse sequelae and lack of an approved antibiotic in some markets.

Recently, there has been an increased interest in the use of intraocular medications after cataract surgery. Much of this interest was stimulated by the results of the European Society of Cataract and Refractive Surgeons clinical trial, which showed the use of intracameral cefuroxime significantly reduced the risk for endophthalmitis.19 Another group studied the use of a regulated and compounded combination of triamcinolone, moxifloxacin, and vancomycin, and found this transzonular intravitreal injection was effective at preventing infection and inflammation.20 Similarly, a study performed at a private practice group evaluating intravitreal triamcinolone–moxifloxacin had comparable results.A Although steroid response resulting in increased intraocular pressure (IOP) is a concern, in particular in glaucoma patients, studies have shown intravitreal triamcinolone to be generally well tolerated.21,22

There are numerous approaches for administering prophylactic medications, including intracameral, pars plana, and transzonular. The transzonular technique has been considered more challenging and disruption of the anterior hyaloid membrane is a concern. Because ophthalmologists around the world use the pars plana approach every day in clinics to treat various retinal conditions, we feel it is a more suitable approach. In this study, we evaluated the safety and efficacy of an intravitreal injection of a steroid (triamcinolone) and antibiotics (moxifloxacin, vancomycin) at the time of cataract surgery using a pars plana approach of administration.

Patients and methods

In addition to complying with the U.S. Health Insurance Portability and Accountability Act of 1996, this project was granted approval from the University of South Dakota Institutional Review Board.

This was a single-center retrospective chart review of eyes from January 2015 to December 2015 that had concurrent cataract surgery and implantation of a trabecular microbypass stent in a private practice setting. All patients had been previously diagnosed with primary open-angle glaucoma.

The patients had a preoperative assessment to establish a baseline. Demographic information (age, sex), corrected distance visual acuity (CDVA), glaucoma medications, and IOP were recorded. To assess outcomes, data were collected at postoperative visits from 1 day, 1 week, 1 month, and 3 months. At each visit, the data collected included IOP, number and type of medications, and CDVA.

The primary outcome measures in the study included IOP by Goldmann applanation tonometry and the number of glaucoma medications. To evaluate safety, the incidence of IOP spikes was also recorded, which was defined as an increase of at least 15 mm Hg from baseline IOP.

The patients were divided into 2 groups. The study group included patients who had a pars plana intravitreal injection of triamcinolone, moxifloxacin, and vancomycin at the time of surgery and a topical NSAID drop daily for 4 weeks after the procedure. The study group is also referred to as the dropless or injection group throughout this paper. The intravitreal injection, which is available in a compounded form, was a 0.2 mL injection of the combination of 15 mg/1 mg/10 mg/mL concentration of triamcinolone, moxifloxacin, and vancomycin, respectively. Therefore, the eye received 3 mg of triamcinolone, 0.2 mg of moxifloxacin, and 2 mg of vancomycin with each injection. Of note, in January of 2016, the center transitioned to a triamcinolone–moxifloxacin only injection because of concerns regarding the potential association between vancomycin and hemorrhagic occlusive retinal vasculitis that has been described previously.23 However, only eyes treated with triamcinolone–moxifloxacin–vancomycin were included in the study population. The control group comprised eyes that received a standard topical regimen postoperatively. In this cohort, patients used a postoperative topical medication regimen consisting of an antibiotic (moxifloxacin 0.05% 4 times a day for 1 week), an NSAID (bromfenac 0.07% or nepafenac 0.3% once daily for 4 weeks), and a steroid (difluprednate 0.05% or prednisolone acetate 1.0% tapered over 4 weeks).

For statistical analysis, a 2 independent-sample t test procedure was used to compare the mean IOP change between groups. A Wilcoxon Mann-Whitney test was used to compare the number of medications used between the 2 groups. A chi-square test was used to test sex dependency between the groups. The Fisher exact test was applied to test the difference between 2 population proportions. The significance level was set at 5%. All data analyses were performed using R software.B

Results

Of the 483 eyes in the study, 234 eyes were in the study group, which received the intravitreal injection of a steroid and antibiotics at the time of surgery, and the remaining 249 eyes were in the control group, which used all topical medications. Table 1 shows the patient demographics and baseline information. Of note, there was a statistically significant difference in mean age, preoperative IOP, and preoperative glaucoma medications between the 2 groups. The study (dropless) group was younger, had lower preoperative IOP readings, and used fewer glaucoma medications at baseline than the control group.

Table 1
Table 1:
Preoperative demographics and baseline measurements.

Figure 1 shows the mean IOP at each timepoint in both groups. The mean IOP increased in both groups 1 day postoperatively.

Figure 1
Figure 1:
Mean IOP measurements (±1 SD) in the 2 groups after cataract surgery with trabecular microbypass stent placement (IOP = intraocular pressure).

Table 2 and Figure 2 show the incidence of IOP spikes in the 2 groups. The total or cumulative spikes at any postoperative visit were statistically similar between the 2 groups. In the dropless or injection group, 48 (20.5%) of 234 eyes experienced at least 1 IOP spike during the follow-up, whereas 33 (13.25%) of 249 eyes in the topical or control group experienced at least 1 IOP spike during the follow-up (P = .038). Four of 234 eyes in the injection group and 3 of 249 eyes in the topical group had repeat pressure spikes (P = .72).

Figure 2
Figure 2:
Percentage of eyes in the 2 groups with an IOP spike of at least 15 mm Hg from baseline (IOP = intraocular pressure).
Table 2
Table 2:
Incidence of IOP spikes by specific criteria.

In the study group, there was a pressure spike of 15 mm Hg or higher at 54 (5.7%) of 936 postoperative visits. In the control group, there was a pressure spike of 15 mm Hg or higher at 37 (3.7%) of 996 postoperative visits. There was no statistically significant difference in the rate of IOP spikes between the 2 groups (P = .051).

Table 3 shows the 3-month postoperative data. There was no statistically significant difference in IOP change from baseline between the 2 groups. However, the control group had a more robust reduction in medication use, which was statistically significant.

Table 3
Table 3:
Three-month postoperative data.

Figure 3 shows the mean number of glaucoma medications at each visit. The difference in the mean reduction in medication use between each group was statistically significant (P < .001).

Figure 3
Figure 3:
Mean number of glaucoma medications (±1 SD) used by patients in both groups after cataract surgery with trabecular microbypass stent placement.

The CDVA assessments were similar between each group at all timepoints.

Discussion

Numerous studies in the peer-reviewed literature have established the usefulness of intravitreal injections as chemoprophylaxis to reduce the likelihood of infection, inflammation, and postoperative discomfort after cataract surgery. This might be because of the poor compliance associated with topical medication regimens. There are multiple factors that contribute to poor compliance with topical regimens, including complicated schedules, expensive costs, difficulty with administration, and irritation from the agents.4,14,15 Recently, companies have started to combine multiple therapies into a single drop. For example, 1 available combination eyedrop is a topical formulation consisting of prednisolone acetate, moxifloxacin hydrochloride, and ketorolac tromethamine (Pred–Moxi–Ketor). Although combination drops simplify regimens, patients are still required to administer drops into their eye numerous times a day.

Overall, the results of this retrospective chart review of 483 eyes are encouraging. The results showed there was IOP reduction in both groups. At 3 months, the mean pressure reduction was 2.59 mm Hg in the study group and 3.63 mm Hg in the control group. The difference in IOP reduction between both groups was similar and was not statistically significant (P = .062). The pressure reduction observed in both groups in this study is consistent with data in previous studies that evaluated the safety and efficacy of the combined procedure.24–27 Furthermore, no eyes required further surgical intervention within the first 3 months to decrease an elevated IOP after surgery. Regarding medication, both groups achieved a mean reduction in medication use 3 months after surgery; however, the control group had a more robust decrease in medication use with 0.8 fewer medications than baseline (P < .001).

The more significant decrease in medication use observed in the control group might be a result of the injected triamcinolone in the vitreous space remaining in the eye much longer than the types of topical steroids administered over 1 month. Previous studies found that clinically significant amounts of triamcinolone can remain for approximately 3 months after intravitreal injections, and furthermore, trace amounts of triamcinolone have been detected in animal models up to 8 months after intravitreal injection.28,29 In the case of the rabbit-eye model, the concentration of the triamcinolone does drop substantially in the first few months.29 This lingering concentration of steroid in the eye might contribute to increased IOP in patients who respond to steroids. However, in this study, both groups had similar reductions in IOP and both achieved reductions in glaucoma medications from baseline.

The incidence of pressure spikes of 15 mm Hg or higher above baseline was a primary outcome of interest in this study. A statistically significant difference was not found between the 2 groups in the cumulative number of pressure spikes (P = .051). Most of the pressure spikes occurred in the first 24 hours after surgery in both groups. These data suggest that despite the lingering steroid in the vitreous (discussed previously), the steroid effect on IOP does not lead to significant pressure increases above baseline days to months after surgery. This finding is consistent with a previous study that evaluated the use of a intracanalicular depot of dexamethasone for slow release of a steroid that did not result in greater incidence of IOP spikes than those experienced by a group that had a standard topical regimen.30

The safety profiles of both groups were favorable. In the study group, there were no reported cases of inflammation, CME, or infection. No retinal detachments (RD) occurred during the 3-month postoperative period. These findings are consistent with previous literature evaluating the pars plana approach of intravitreal injections that found infection rates and RD rates were less than 1.0%.31 Furthermore, the use of topical povidone–iodine, which is already part of the cataract surgery preparation, has been shown to decrease postintravitreal injection endophthalmitis rates even more.32

In addition, the usefulness of intraocular antibiotics in preventing endophthalmitis has been shown previously. One study showed that intracameral cefuroxime had a 100% success rate in preventing postsurgical endophthalmitis.33 Another study34 found that intracameral moxifloxacin resulted in a statistically significant reduction in endophthalmitis rates compared with patients who received topical chemoprophylaxis. Last, another study could not find an appreciable difference in the effectiveness of preventing postoperative endophthalmitis between intraocular moxifloxacin and cefuroxime, and both of these intracameral options were better than topical antibiotics in preventing infection.35 One can see the benefits associated with using intraocular antibiotics for chemoprophylaxis.

Our study was not without limitations. It was an open-label nonrandomized study. The use of the stent in both groups could have mitigated the effect of the steroid on pressure. At baseline, the 2 groups were statistically different in terms of age, IOP, and baseline glaucoma medications. This difference at baseline might contribute to challenges in comparing medication reduction between the 2 groups. However, it should be emphasized that the study group represented the final 234 eyes that had the triamcinolone–moxifloxacin–vancomycin intravitreal injection immediately before the site transitioned to an injection containing only triamcinolone and moxifloxacin. No additional inclusion or exclusion criteria were used in the study group to prevent selection bias and to mimic the clinical use of the intravitreal injection approach.

From this study, there are numerous avenues for further evaluation. Future studies could focus on the safety and efficacy of the currently used injection of triamcinolone and moxifloxacin without vancomycin. Additional research could explore the rate of pressure spikes in nonglaucomatous eyes versus glaucomatous eyes using the intravitreal approach. Previously, subconjunctival, intracameral, and transzonule intravitreal triamcinolone injections have been shown to be generally well tolerated without significant pressures spikes when administered in conjunction with phacoemulsification only.20,36,37 There have also been reports of significant pressure elevations after intravitreal steroid injection; however, these occurred when treating macular edema and retinal neovascularization in nonglaucomatous eyes.38

Although the most critical aspect of intravitreal administration is reducing the risk for infection, pain, and other adverse events, patient experience is also an important consideration. For some patients, the highest out-of-pocket expense in the entire process are the drops after surgery. This present study did not use surveys and/or reviews to assess patient satisfaction with either regimen. However, a previous study39 found that patients prefer the intravitreal injection over the topical regimen. In addition, triamcinolone injections often cause visual disturbances (eg, floaters), and using a clear steroid solution such as dexamethasone might alleviate this problem. Future studies focusing on the patient experience between the 2 approaches would be beneficial.

With no exclusion criteria, this study mimics the clinical use of the intravitreal approach for delivering medications after cataract surgery. The early results from this study suggest that the intravitreal approach of administering medications might be a safe and effective option for glaucomatous eyes having cataract surgery with concomitant trabecular microbypass stent insertion. Although further studies are required to solidify its role for both glaucomatous and nonglaucomatous eyes, our study suggests clinicians might consider the pars plana intravitreal injection of steroid and antibiotic as an alternative to topical regimens after cataract surgery.

What Was Known

  • Patient compliance with eyedrop medications is not outstanding.
  • Intracameral and intravitreal antibiotics have been shown to be better than topical antibiotics in preventing postoperative endophthalmitis.

What This Paper Adds

  • Pars plana intravitreal injection of a steroid and antibiotics with a topical NSAID seemed to be a safe and effective option for reducing postoperative pain, inflammation, CME, and endophthalmitis.
  • The intravitreal injection of triamcinolone–moxifloxacin–vancomycin did not contribute to significant pressure increases after cataract surgery in glaucomatous eyes.

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Disclosures

Drs. Ibach, Schweitzer, and Berdahl are consultants to and speakers for Glaukos Corp. None of the other authors has a financial or proprietary interest in any material or method mentioned.

Other Cited Material

A. Galloway MS, “Intravitreal Placement of Antibiotic/Steroid as Substitute for Postoperative Drops After Cataract Surgery,” presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, April 2014. Abstract available at: https://ascrs.confex.com/ascrs/14am/webprogram/Paper8473.html. Accessed November 7, 2017
B. R Development Core Team. The R Project for Statistical Computing. Vienna, Austria, R Foundation for Statistical Computing. Available at: https://www.r-project.org/. Accessed November 7, 2017
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