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The Effects of Two Non-Steroidal Anti-Inflammatory Drugs, Bromfenac 0.1% and Ketorolac 0.45%, on Cataract Surgery

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The Effects of Two Non-Steroidal Anti-Inflammatory Drugs, Bromfenac 0.1% and Ketorolac 0.45%, on Cataract Surgery Original Article Yonsei Med J 2015 Nov;56(6):1671-1677 http://dx.doi.org/10.3349/ymj.2015.56.6.1671 pISSN: 0513-5796 · eISSN: 1976-2437 The Effects of Two Non-Steroidal Anti-Inflammatory Drugs, Bromfenac 0.1% and Ketorolac 0.45%, on Cataract Surgery Ji Won Jung1,2, Byung Hoon Chung1, Eung Kweon Kim1,3, Kyoung Yul Seo1, and Tae-im Kim1 1Department of Ophthalmology, Severance Hospital, Corneal Dystrophy Research Institute, Yonsei University College of Medicine, Seoul; 2Department of Ophthalmology and Inha Vision Science Laboratory, Inha University School of Medicine, Incheon; 3Institute of Vision Research, Severance Biomedical Science Institute, Brain Korea 21 Plus Project for Medical Science, Yonsei University College of Medicine, Seoul, Korea. Purpose: To compare the additive effects of two types of non-steroidal anti-inflammatory drugs (NSAIDs), bromfenac 0.1% or ke- torolac 0.45%, relative to topical steroid alone in cataract surgery. Materials and Methods: A total 91 subjects scheduled to undergo cataract operation were randomized into three groups: Group 1, pre/postoperative bromfenac 0.1%; Group 2, pre/postoperative preservative-free ketorolac 0.45%; and Group 3, postoperative steroid only, as a control. Outcome measures included intraoperative change in pupil size, postoperative anterior chamber in- flammation control, change in macular thickness and volume, and ocular surface status after operation. Results: Both NSAID groups had smaller intraoperative pupil diameter changes compared to the control group (p<0.05). There was significantly less ocular inflammation 1 week and 1 month postoperatively in both NSAID groups than the control group. The changes in central foveal subfield thickness measured before the operation and at postoperative 1 month were 4.30±4.25, 4.87±6.03, and 12.47±12.24 μm in groups 1 to 3, respectively. In the control group, macular thickness and volume increased more in patients with diabetes mellitus (DM), compared to those without DM. In contrast, in both NSAID groups, NSAIDs significantly reduced macular changes in subgroups of patients with or without DM. Although three ocular surface parameters were worse in group 1 than in group 2, these differences were not significant. Conclusion: Adding preoperative and postoperative bromfenac 0.1% or ketorolac 0.45% to topical steroid can reduce intraopera- tive miosis, postoperative inflammation, and macular changes more effectively than postoperative steroid alone. Key Words: Non-steroidal anti-inflammatory drugs, miosis, ocular inflammation, macular edema INTRODUCTION NSAIDs are potent inhibitors of cyclooxygenase (COX) en- zymes, they inhibit production of pro-inflammatory prosta- Non-steroidal anti-inflammatory drugs (NSAIDs) provide sev- glandins, which cause vasodilation and increased vascular eral benefits in intraocular and refractive surgery. Because permeability.1 Therefore, NSAIDs are used to maintain pupil- lary dilation during surgery, to reduce postoperative pain, to Received: October 22, 2014 Revised: December 21, 2014 Accepted: December 23, 2014 control inflammation during and after surgery, and to inhibit Corresponding author: Dr. Tae-im Kim, Department of Ophthalmology, Yonsei development of cystoid macular edema (CME) after cataract University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. surgery.2-4 Tel: 82-2-2228-3570, Fax: 82-2-312-0541, E-mail: [email protected] Topical NSAID eye drops gained attention as an alternative •The authors have no financial conflicts of interest. treatment to topical steroids for postoperative pain and inflam- © Copyright: Yonsei University College of Medicine 2015 mation because they are associated with fewer complications, This is an Open Access article distributed under the terms of the Creative Com- such as increased intraocular pressure, infection, and delayed mons Attribution Non-Commercial License (http://creativecommons.org/ licenses/ 5-8 by-nc/3.0) which permits unrestricted non-commercial use, distribution, and repro- corneal epithelial wound healing. Concurrent administra- duction in any medium, provided the original work is properly cited. tion of corticosteroids and NSAIDs has shown potential syner- www.eymj.org 1671 Effects of Bromfenac 0.1% and Ketorolac 0.45% gistic activity in some studies.5,9,10 Food and Drug Administra- and the study medications were masked to both the surgeon tion (FDA)-approved NSAIDs currently used for cataract surgery and examiners. The administration of the topical NSAIDs was include diclofenac, ketorolac, nepafenac, and bromfenac.5 determined based on the suggested regimen of each pharma- Bromfenac sodium 0.1% ophthalmic solution (Bronuck®, ceutical company. Group 1 patients were instructed to apply 1 Senju Pharmaceutical Co., Ltd., Osaka, Japan) has clinical in- drop of bromfenac sodium hydrate ophthalmic solution 0.1% dications for treating postoperative inflammation, blepharitis, twice daily beginning 3 days before surgery and two drops at conjunctivitis, and scleritis.5 Preservative-free ketorolac 0.45% 20 minute intervals at 2 hours before surgery. They continued solution (Acuvail®, Allergan Inc., CA, USA) is also targeted for using bromfenac 0.1% twice-daily with other postoperative postoperative use after cataract surgery.11 eye drops for 4 weeks. Group 2 patients were instructed to in- Several reports identified corneal complications of using still 1 drop of ketorolac 0.45% ophthalmic solution twice-daily early-generation topical NSAIDs, including corneal melting beginning 1 day prior to cataract surgery and 2 drops at 20 caused by the generic form of diclofenac, as well as ketorolac minute intervals at 2 hours before surgery, with continued ap- and nepafenac; these reports prompted subsequent decline plication twice-daily throughout the first 2 postoperative weeks. in the use of topical NSAIDs after ocular surgery.12,13 However, Control eyes in Group 3 did not receive any additional medi- Flach13 demonstrated that not only simple drug toxicity but cations. Postoperatively, patients in all three groups were pre- also coexistent factors, such as concurrent ocular and system- scribed topical gatifloxacin 0.3% and prednisolone acetate 1% ic disease, inconsistent and variable doses, and other medica- eye drops that were to be applied 4 times daily for 4 weeks. tions used simultaneously, were attributable to corneal melt- ing. Since then, many clinical trials have established the efficacy Surgical technique and safety of other topical NSAIDs14,15 and they are being used All cataract surgeries were phacoemulsification with intraoc- again in ophthalmic surgery. ular lens (IOL) implantation after topical anesthesia with pro- In this study, we report the results of a prospective, random- paracaine hydrochloride 0.5% eye drops by a single surgeon ized clinical trial that compared two kinds of NSAID eye drops, (T.I. Kim). The surgical procedure consisted of a clear cornea with different application schedules, for use in combination incision on the steep axis, capsulorrhexis, phacoemulsification, therapy with topical steroid for cataract surgery. and IOL placement in the capsular bag. Outcome measures MATERIALS AND METHODS Outcome measures comprised changes in pupil size during sur- gery, postoperative anterior chamber inflammation, macular This single-center, randomized study was approved by the Sev- thickness and volume, and change in the ocular surface status. erance Hospital Institutional Review Board, Seoul, South Ko- Patients were evaluated on postoperative days 1, 7, and 28. Hori- rea. Participants consisted of 91 patients who were scheduled zontal pupillary diameters were measured in 0.5 mm units us- for cataract surgery between November 2013 and June 2014. ing a sterile caliper over the cornea and measurements were All patients gave written informed consent before enrollment, taken under a microscope upon the initiation of the surgery and clinical research was performed in accordance with the and before the insertion of the ophthalmic viscosurgical de- tenets of the Helsinki Declaration. vice (OVD) for IOL implantation. Ocular inflammation was as- Inclusion criteria for enrollment were as follows: males or sessed, and the summed ocular inflammation score (SOIS) was non-pregnant females aged between 20- to 80-years-old. Ex- calculated by adding the subject’s anterior chamber cells and clusion criteria were as follows: poor general condition, in- flare grades (range, 0–4) at 1 week and 1 month postoperatively.16 cluding high blood pressure, poor blood glucose control, or All OCT images were obtained using the Spectralis SD-OCT renal failure; history of ocular trauma or disease; history of in- (Heidelberg Engineering, Carlsbad, CA, USA), and the macu- traocular surgery; systemic or topical NSAIDs or corticoste- lar retinal thickness and volume map analysis protocol was roids use within 4 weeks of enrollment; known hypersensitivi- used to evaluate the macular state.17 The central foveal sub- ty to salicylates or other NSAIDs; and use of alpha-1 adrenergic field (CSF) thickness was defined as the average of all points antagonist or other analogous systemic medications that may in the inner circle within 1 mm radius from the fovea, and mac- increase the tendency for miosis during the operation (intraop- ular thickness was determined as the average thickness of five erative floppy iris syndrome). subfields, including the CSF and nasal, temporal, superior, Patients were enrolled in the study during a preoperative and inferior inner segments
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