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Topical Ketorolac in Vitreoretinal SurgeryA Prospective, Randomized, Placebo-Controlled, Double-Masked Trial
Stephen J. Kim, MD;
Wayne R. Lo, MD;
G. Baker Hubbard III, MD;
Sunil K. Srivastava, MD;
John P. Denny, MD;
Daniel F. Martin, MD;
Jiong Yan, MD;
Chris S. Bergstrom, MD;
Blaine E. Cribbs, MD;
Bryan J. Schwent, MD;
Thomas M. Aaberg Sr, MD, MSPH
Arch Ophthalmol. 2008;126(9):1203-1208.
ABSTRACT
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Objective To evaluate the effects of topical ketorolac in patients undergoing vitreoretinal surgery.
Methods One hundred nine patients undergoing vitrectomies were randomized to receive either topical ketorolac tromethamine, 0.4%, or placebo. Patients were instructed to begin taking the study medication 3 days preoperatively (4 times daily) and to continue taking it 4 weeks postoperatively.
Main Outcome Measures Intraoperative pupil diameter, postoperative day 1 pain and inflammation, 1-month postoperative retinal thickness, and preoperative and 1-month postoperative best-corrected visual acuities.
Results The difference in mean pupil diameters between patients using ketorolac and those taking placebo was 0.06 mm (P = .39). Patients taking ketorolac and those taking placebo had mean pain scores (scale, 1-10) of 0.24 (SD, 0.6) and 1.06 (SD, 2) (P = .03) and mean inflammation grades (grade, 0-4) of 0.59 (SD, 0.7) and 1.16 (SD, 0.9) (P < .001), respectively. Ketorolac reduced central subfield thickness by 8%, but this was not statistically significant. At 1 month, mean visual acuities improved to 0.40 logMAR units (mean Snellen, 20/50; SD, 0.28 logMAR units) in the ketorolac group from 0.83 logMAR units (20/150+2; SD, 0.60 logMAR units) at baseline and to 0.67 logMAR units (20/100+1; SD, 0.46 logMAR units) in the placebo group from 0.92 logMAR units (20/150–2; SD, 0.62 logMAR units) at baseline (P = .001).
Conclusions Topical ketorolac was well tolerated and safe, reduced postoperative pain and inflammation, and improved visual recovery in this prospective, double-masked trial.
Application to Clinical Practice Topical ketorolac may benefit patients undergoing vitreoretinal surgery.
Trial Registration clinicaltrials.gov Identifier: NCT00576329
INTRODUCTION
Although recent advances in modern vitreoretinal surgery have improved visual and anatomic outcomes, postoperative discomfort and delayed visual recovery continue to present significant challenges. A prospective study by Fekrat and colleagues1 concluded that 56% of patients have eye pain after vitreoretinal surgery. Furthermore, Staudt and colleagues2 reported that 80% of patients show evidence of angiographic leakage after macular hole surgery ( 4 months). Treatment strategies that improve on these concerns would be advantageous.
Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes and thereby the synthesis of proinflammatory prostaglandins. Prostaglandins are synthesized in the ciliary body and iris in response to trauma or surgery3 and promote miosis, pain, and inflammation.4-5 Several prospective, randomized, clinical studies have demonstrated the efficacy of topical NSAIDs to inhibit miosis,6-9reduce postoperative pain and inflammation,10-11 prevent cystoid macular edema,12-13 and improve visual recovery after cataract surgery.14 However, no study to date has evaluated these potential benefits of topical NSAIDs in vitreoretinal surgery. This prospective, randomized, placebo-controlled, double-masked trial was designed and initiated to evaluate the potential effects of topical ketorolac tromethamine, 0.4% (Acular LS; Allergan Pharmaceuticals, Irvine, California), on intraoperative mydriasis and pain, inflammation, retinal thickness, and visual acuity after vitrectomy surgery.
METHODS
The Emory University (Atlanta, Georgia) institutional review board approved this study and all participants gave informed consent before enrollment. This study adhered to the tenets of the Declaration of Helsinki and was in full compliance with all Health Insurance Portability and Accountability Act regulations. All study participants were recruited and examined and underwent routine vitrectomy surgery at the Emory Eye Center between November 2006 and October 2007.
Male and female patients aged 18 years or older who were scheduled for elective vitrectomy were eligible for study inclusion. Exclusion criteria consisted of intraocular surgery of any type within 3 months of enrollment, history of pupil trauma or scarring, allergy to NSAIDs, requirement of intraoperative mechanical dilation, use of topical or systemic NSAIDs or corticosteroids within 1 week of surgery, treatment with intravitreal or sub-Tenon injection of a corticosteroid within 3 months of surgery, previous enrollment of the fellow eye in the study, history of uveitis, and inability to comply with study instructions.
Each study eye was assigned by a computer-generated randomization schedule to receive either ketorolac tromethamine, 0.4%, or placebo (Refresh Tears; Allergan Pharmaceuticals) in a double-masked fashion. On postoperative day 1, pain was recorded by a technician masked to study group after instructing patients to grade their own pain using a scale from 1 to 10, in which 1 represents minimal discomfort; 2 to 3, mild pain; 4 to 6, moderate pain; 7 to 9, severe pain; and 10, the worst discomfort the patient had ever experienced. Intraocular inflammation was graded on postoperative day 1 by an investigator masked to study group using the Standardization of Uveitis Nomenclature Working Group grading classification.15 According to this grading scheme, less than 1 cell (in a 1 mm2 field) equals 0, 1 to 5 cells equals 0.5, 6 to 15 cells equals 1, 16 to 25 cells equals 2, 26 to 50 cells equals 3, and more than 50 cells equals 4. By using a combination of pinhole and refraction methods, a technician masked to study group obtained best-corrected Snellen visual acuity at baseline and at the 1-month postoperative visit. Optical coherence tomography (OCT3; Zeiss-Humphrey Systems, Dublin, California) was performed at the 1-month visit.
Study participants self-administered 1 drop of the study drug 4 times daily beginning 3 days before surgery and then administered 1 drop every 5 minutes for a total of 3 doses starting 1 hour before their surgery. This schedule was based on the work of Donnenfeld and coworkers.16 All patients received a standard preoperative dilating regimen consisting of 1 drop each of phenylephrine hydrochloride, 2.5%, cyclopentolate hydrochloride, 1%, and atropine sulfate, 1%, every 5 minutes for 3 consecutive doses 1 hour before surgery. All study participants were placed on a standardized postoperative regimen (beginning on postoperative day 1), which consisted of atropine sulfate, 1% (twice daily), and an antibiotic (4 times daily) for 1 week, the study drug (4 times daily) for 4 weeks, and prednisolone acetate, 1%, 4 times daily but then tapered by 1 drop per week until it was discontinued after 4 weeks. All preoperative medications, including aspirin and systemic NSAIDs, were restarted after surgery and additional topical medications, such as aqueous suppressants, were added if the surgeon considered it necessary.
Patient characteristics, including age, sex, race, presence of diabetes, medication use (within broad categories, eg, angiotensin-converting enzyme inhibitors), and lens status, were recorded. History of laser photocoagulation, intraocular surgery, and treatment with an intravitreal or sub-Tenon injection of a corticosteroid was documented from review of patients' medical records. Age was recorded at the time of the preoperative visit. Race and sex were self-reported. Diabetes was recorded as being either insulin-dependent or not.
Both vertical and horizontal pupil diameters were measured by investigators masked to study group using Castroviejo calipers before the first incision and at the end of surgery before introduction of gas or silicone oil. Duration of surgery, total infusion volume, addition of epinephrine to the infusion solution (concentration of 300 µg/500 mL), use of gas or silicone oil, staining of vitreous or membranes with triamcinolone acetonide (Kenalog-40; Bristol-Myers Squibb, Princeton, New Jersey), and intraoperative complications were carefully recorded. Treatment with an intravitreal or sub-Tenon injection of triamcinolone acetonide intraoperatively or postoperatively was noted. Postoperative complications were reviewed and documented.
The surgical procedure was a standard 3-port pars plana vitrectomy. No patients underwent scleral buckling. Use of either standard 20-gauge or sutureless 25- or 23-gauge systems and all other surgical procedures, including type of anesthesia (general vs local) and addition of epinephrine to the infusion solution, were dictated by the individual preference of the surgeon.
A trained technician masked to study group performed optical coherence tomography, with close monitoring of patient fixation under direct observation. Optical coherence tomographic images were generated with the use of six 6-mm radial scans in a spokelike pattern according to manufacturer protocol.17 For the purposes of this study, maximal retinal thickness in microns was analyzed in the center of the fovea (center point thickness) and in the central subfield. Total macular volume was analyzed in millimeters cubed. The numerical values for these parameters were directly obtained from the retinal map algorithm. Scans were evaluated for decentration and artifacts and were retaken as necessary to obtain adequate images through the foveal center.
SAMPLE SIZE CALCULATION
Based on the work of Chan and colleagues18 and Kim and coworkers,19 a 40-µm (approximately 20%) difference in retinal thickness on optical coherence tomography was considered clinically significant. An inference of means analysis estimated that 49 eyes in each group would provide 80% power (P = .05) to detect a 40-µm (SD, 70 µm) difference. Therefore, assuming a 10% loss of follow-up, a recruitment objective of 55 patients for each group was established.
STATISTICAL ANALYSIS
Descriptive statistics were calculated for case characteristics. Group comparisons were performed with the Wilcoxon rank-sum test using 2-sided analysis. P< .05 was considered significant. Snellen visual acuity was converted to logMAR units for analysis purposes. Counting fingers vision was recorded as 1.85 logMAR units, hand motion vision as 2.3 logMAR units.20 No eyes had worse than hand motion vision. Data are given as mean (SD).
RESULTS
A total of 109 participants (109 eyes) were enrolled and underwent uncomplicated vitrectomies. Fifty-five patients were randomized to ketorolac and 54 patients were randomized to placebo. Baseline characteristics of the ketorolac and placebo groups are summarized in Table 1. The mean preoperative visual acuities of the ketorolac and placebo groups were 0.83 (0.60) logMAR units (mean Snellen, 20/150+2) and 0.92 (0.62) logMAR units (mean Snellen, 20/150–2), respectively.
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Table 1. Baseline Characteristics of Patients Undergoing Vitreoretinal Surgery Randomized to Receive Ketorolaca or Placebo
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Surgical characteristics of the ketorolac and placebo groups are summarized in Table 2. Surgical complications were uncommon overall but more frequent in the placebo group. There was 1 retinal detachment (2%), 1 nonclearing vitreous hemorrhage (2%), 1 failure of macular hole closure (2%), and 1 newly developed macular hole after surgery (2%) in the placebo group compared with only 1 failure of macular hole closure (2%) in the ketorolac group. In addition, 1 eye treated with ketorolac had placement of silicone oil at the end of surgery. Consequently, 103 eyes (94%) had complete follow-up with optical coherence tomography.
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Table 2. Characteristics of Vitreoretinal Surgery by Randomization to Ketorolaca or Placebo
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The mean preincisional vertical and horizontal pupil diameters of the study cohort were 7.5 (1.0) and 7.4 (1.1) mm, respectively, which increased slightly to 7.7 (1.1) and 7.5 (1.1) mm by the end of surgery (data not shown). The mean changes in pupil diameter from preincision to the end of surgery for patients treated with ketorolac and placebo were 0.10 (0.60) and 0.16 (0.54) mm, respectively (P = .39) (Figure 1). Epinephrine (added to the infusion solution) and brown iris color were both independently associated with increased pupil diameter (data not shown). Therefore, a potentially masked mydriatic effect of ketorolac was examined in the absence of epinephrine and according to iris color, but no effect was observed.
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Figure 1. Change in mean pupil diameter from preincision to end of vitreoretinal surgery in patients treated with topical ketorolac tromethamine, 0.4%, or placebo. Light eyes included hazel, amber, green, and gray.
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On postoperative day 1, the ketorolac group had a mean pain score of 0.24 (0.6) compared with 1.06 (2.0) in the placebo group (P = .03) (Figure 2). Most patients in the ketorolac (n = 42 [76%]) and placebo (n = 35 [65%]) groups had a pain score of 0. No patient in the ketorolac group had a pain score of 3 or greater; in contrast, 11 patients in the placebo group (20%) had a pain score of 3 or greater, with a highest recorded pain score of 9 (1 patient).
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Figure 2. Distribution of pain scores on day 1 after vitreoretinal surgery in patients treated with ketorolac topical tromethamine, 0.4%, or placebo (P = .03).
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On postoperative day 1, the ketorolac group had significantly less inflammation than the placebo group, with a mean grade of 0.59 (0.7) vs 1.16 (0.9), respectively (P < .001) (Figure 3). A total of 21 patients (38%) treated with ketorolac and 5 patients (9%) given placebo had an inflammation grade of 0, while 1 patient (2%) treated with ketorolac and 6 patients (11%) given placebo had inflammation grades of 3. No patients had inflammation grades greater than 3 in this study.
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Figure 3. Distribution of inflammation severity on day 1 after vitreoretinal surgery in patients treated with topical ketorolac tromethamine, 0.4%, or placebo (P < .001).
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At 1 month, the ketorolac and placebo groups had mean center point thicknesses of 254 (92) and 276 (121) µm (P = .55) and mean central subfield thicknesses of 277 (81) and 299 (105) µm, respectively (P = .43). The mean total macular volumes for the ketorolac and placebo groups were 7.58 (1.1) and 8.03 (1.3) mm3, respectively (P = .14) (Figure 4).
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Figure 4. Box plot of center point thickness (A), central subfield thickness (B), and total macular volume (C) 1 month after vitreoretinal surgery in eyes treated with topical ketorolac tromethamine, 0.4%, or placebo. Horizontal lines denote medians; the bottom and top of the boxes represent 25th and 75th percentiles, respectively; error bars represent 95% confidence intervals; and the dots are outliers.
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At 1 month, mean visual acuities improved to 0.40 (0.28) logMAR units (mean Snellen, 20/50) in the ketorolac group and 0.67 (0.46) logMAR units (mean Snellen, 20/100+1) in the placebo group (P = .001), which represented a mean improvement from baseline of 4.3 and 2.5 lines of vision, respectively (Figure 5). Patients in the ketorolac group with visual acuities of 20/200 or less (poor visual acuity) or 20/60 to 20/100 (intermediate visual acuity) preoperatively had significantly greater improvement in visual acuity at 1 month compared with patients in the placebo group with visual acuities of 20/200 or less (P = .03) or 20/60 to 20/100 (P = .05) (Figure 6).
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Figure 5. Box plot of visual acuity before and after vitreoretinal surgery in eyes treated with topical ketorolac tromethamine, 0.4%, or placebo. Difference in 1-month visual acuity was significant (P = .001).
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Figure 6. Box plot of poor ( 20/200), intermediate (20/60-20/100), and good (20/20-20/50) preoperative visual acuity before and 1 month after vitreoretinal surgery in eyes treated with topical ketorolac tromethamine, 0.4%, or placebo. Difference between the ketorolac and placebo groups at 1 month was significant for eyes with poor (P = .03) or intermediate (P = .05) but not good (P = .38) preoperative visual acuity.
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The most commonly reported adverse event was mild stinging and tearing in 5 of 55 patients (9%) treated with ketorolac and 2 of 54 patients (4%) given placebo. This was minimal in all cases except for 1 patient (2%) in the ketorolac group, resulting in early cessation of the drug after 2 weeks of use.
COMMENT
This prospective, randomized, placebo-controlled, double-masked trial is, to our knowledge, the first report of the effects of topical NSAIDs in eyes undergoing vitrectomy surgery, though their use in cataract surgery has become common.6-14 This study did not observe a benefit of ketorolac over placebo on intraoperative mydriasis but did observe significant differences in favor of ketorolac with respect to pain, inflammation, and 1-month best-corrected visual acuity.
Although epinephrine and brown iris color were both independently associated with mydriasis in this study, a mydriatic effect was not seen in patients treated with ketorolac. This latter finding contrasts several articles demonstrating a mydriatic effect of NSAIDs in cataract surgery.6-9 However, the use of atropine sulfate, 1%, preoperatively (not routinely used in cataract surgery) and epinephrine in most study eyes (62%) may have limited our ability to detect a difference. Furthermore, surgical manipulation is performed adjacent to the iris plane in cataract surgery with greater tendency for iris disturbance and trauma than in vitrectomy surgery. Combined, all these factors could have influenced our ability to detect the mydriatic effect of ketorolac.
The difference in mean pain scores between the ketorolac and placebo groups was less than 1 (on a scale of 1-10), as most patients had pain scores of 0. However, a total of 11 patients given placebo (20%) had pain scores of 3 or greater compared with no one in the ketorolac group. Thus, ketorolac reduced or prevented moderate and severe pain. We did not record use of narcotic pain medication, which was routinely prescribed to all patients after surgery. It is our impression, however, that patients given placebo were more likely to request and use narcotic pain medication in the immediate postoperative period, which may have resulted in underestimation of pain in the placebo group. Therefore, our finding supports the results of Fekrat and colleagues21 and Vlajkovic and colleagues,22 who independently showed that intravenous ketorolac significantly reduced pain and nausea after vitreoretinal surgery. Thus, NSAIDs are useful in reducing postoperative pain and improving patient comfort. This is particularly relevant in vitreoretinal surgery, in which patient compliance with postoperative procedures and positioning can markedly affect surgical outcome. Furthermore, topical NSAIDs are a safer means of prophylaxis given the increased risk of bleeding associated with their systemic use.
The anti-inflammatory effect of ketorolac was substantial, with 4 times as many patients who were treated with ketorolac having inflammation scores of 0 compared with placebo (21 vs 5 patients). Ketorolac reduced the incidence of moderate to severe inflammation, with only 1 patient treated with ketorolac having an inflammation score of 3 compared with 6 patients in the placebo group. Ketorolac's anti-inflammatory effect may be clinically beneficial. We observed that increased severity of inflammation significantly correlated with increased retinal thickness (data not shown) and that increased retinal thickness, in turn, resulted in reduced visual improvement (data not shown). As such, interventions that reduce postoperative inflammation should directly decrease retinal thickening and consequently improve visual recovery.
Ketorolac, on average, reduced both center point thickness and central subfield thickness by approximately 9% and 8%, respectively, and reduced total macular volume by approximately 6%. Although none of these differences was statistically significant, future studies with larger sample sizes may be warranted given the favorable trends observed in this study.
Overall, at 1 month postoperatively, patients treated with ketorolac had a visual acuity of almost 3 lines greater than those given placebo. Patients in the ketorolac group with intermediate (20/60-20/100) or poor ( 20/200) preoperative visual acuity experienced significantly greater improvement in visual acuity compared with patients in the placebo group. In addition, there was a suggestion of better visual outcomes among those in the ketorolac group with good preoperative visual acuity (20/20-20/50), but this was not statistically significant. Those with good preoperative visual acuities have more limited opportunities for improvement, and thus, not surprisingly, any treatment effect in this group would be difficult to demonstrate.
Although treatment with ketorolac in our study resulted in better 1-month best-corrected visual acuity, its ultimate effect on long-term visual outcomes remains unknown. It has been reported recently that patients with previously closed macular holes who develop cystoid macular edema after cataract extraction have a 7-fold increased risk of their macular holes reopening.23 In this regard, it is interesting that 1 patient given placebo who developed severe inflammation (score of 3) after epiretinal membrane surgery developed a macular hole. Therefore, it seems plausible that the anti-inflammatory effect of ketorolac may reduce such complications and thereby favorably affect long-term visual outcomes.
Although there are several strengths of this study inherent to its prospective, randomized, double-masked design, the sample size was small and thus rare events or outcomes may have had a disproportionate effect on our results. Moreover, we cannot rule out the possibility that differences in baseline characteristics may explain some of our observations. Finally, we did not measure visual acuity using the more standardized Early Treatment Diabetic Retinopathy Study charts. Therefore, we encourage independent verification of our findings.
In conclusion, efforts to improve patient safety, comfort, and visual recovery after vitreoretinal surgery should be encouraged. Topical ketorolac was well tolerated in this prospective clinical trial and effectively reduced pain and inflammation and improved visual recovery after vitrectomy surgery. Given ketorolac's excellent overall safety profile, its use in vitreoretinal surgery should be considered.
AUTHOR INFORMATION
Correspondence: Stephen J. Kim, MD, Vanderbilt Eye Institute, 2311 Pierce Ave, Nashville, TN 37232 (skim30{at}gmail.com).
Submitted for Publication: January 8, 2008; final revision received April 20, 2008; accepted April 24, 2008.
Financial Disclosure: Allergan Pharmaceuticals provided both study drugs. Dr Hubbard is a paid consultant for Genentech Corporation and Theragenics Corporation.
Funding/Support: This study was supported in part by an unrestricted grant from Research to Prevent Blindness, by the Heed Foundation (Dr Kim), and by the Ronald G. Michels Foundation (Dr Kim).
Disclaimer: We confirm that we had full access to all the data in this report and take responsibility for the integrity of the data and the accuracy of the analysis and presentation as well as the decision to submit for publication. This report is not being submitted elsewhere for publication.
Author Affiliations: Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia. Dr Kim is now with the Department of Ophthalmology, Vanderbilt University, Nashville, Tennessee.
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