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Comparison of Effect of Nepafenac and Diclofenac Ophthalmic Solutions

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Comparison of Effect of Nepafenac and Diclofenac Ophthalmic Solutions Journal name: Clinical Ophthalmology Article Designation: Clinical Trial Report Year: 2016 Volume: 10 Clinical Ophthalmology Dovepress Running head verso: Kawahara et al Running head recto: Nepafenac versus diclofenac ophthalmic solutions after cataract surgery open access to scientific and medical research DOI: http://dx.doi.org/10.2147/OPTH.S101836 Open Access Full Text Article CLINICAL TRIAL REPORT Comparison of effect of nepafenac and diclofenac ophthalmic solutions on cornea, tear film, and ocular surface after cataract surgery: the results of a randomized trial Atsushi Kawahara1–3 Background: The aim of this study was to compare the effects of nepafenac ophthalmic Tsugiaki Utsunomiya4 suspension 0.1% (Nevanac) and diclofenac sodium ophthalmic solution 0.1% (Diclod) on the Yuji Kato2 cornea, tear film, and ocular surface after cataract surgery. Yoshinori Takayanagi3 Methods: A total of 60 eyes (60 patients) were selected for this study, with no ocular diseases other than cataract (scheduled for cataract surgery by one surgeon). Patients were randomly 1Department of Ophthalmology, Sapporo Tokushukai Hospital, Sapporo, enrolled to receive nepafenac or diclofenac in the perioperative period, and cataract surgery Hokkaido, Japan; 2Sapporo Kato Eye was performed using torsional microcoaxial phacoemulsification and aspiration with intraocular For personal use only. Clinic, Sapporo, Hokkaido, Japan; lens implantation via a transconjunctival single-plane sclerocorneal incision at the 12 o’clock 3Takayanagi Clinic, Kushiro, Hokkaido, Japan; 4Department of Ophthalmology, position. We compared intra- and intergroup differences preoperatively and postoperatively in Asahikawa Medical University, conjunctival and corneal fluorescein staining scores, tear film breakup times, Schirmer’s tests, Asahikawa, Hokkaido, Japan the Dry Eye Related Quality of Life Scores, and tear meniscus areas using anterior segment optical coherence tomography. Results: The diclofenac group had significantly higher conjunctival and corneal fluorescein staining scores at 4 weeks postoperatively compared with the nepafenac group (P,0.001). Within the diclofenac group, significantly higher conjunctival and corneal fluorescein staining scores were noted at 4 weeks postoperatively than those seen preoperatively (P,0.001) and at 1 week postoperatively (P,0.001). No statistically significant differences were found in any Clinical Ophthalmology downloaded from https://www.dovepress.com/ by 54.70.40.11 on 27-Dec-2018 other items. Conclusions: Nepafenac ophthalmic suspension 0.1% is considered safe for the corneal epithelium after cataract surgery. Keywords: nepafenac, diclofenac, cornea, tear film, ocular surface, cataract surgery Introduction Currently, two drug groups are used to control inflammation after cataract surgery: steroids and nonsteroidal anti-inflammatory drugs (NSAIDs). Although ophthalmic steroids reduce postoperative inflammation by inhibiting phospholipase A2 produc- tion, their use may increase the risk for intraocular pressure elevation or infection.1 NSAIDs exert an equivalent anti-inflammatory effect by inhibiting cyclooxygenases (COXs), but steroid adverse effects can be avoided. Topical NSAIDs have become Correspondence: Atsushi Kawahara widely accepted for controlling ocular inflammation and are more recommended than Takayanagi Clinic, 1-3-5, Minamiodori, Kushiro, Hokkaido 085-0841, Japan topical steroids for the control of inflammation after cataract surgery.2–4 Tel +81 154 43 0211 The most common adverse effects of topical NSAIDs are reported to be stinging, Fax +81 154 43 0210 Email [email protected] irritation, superficial punctate keratitis, corneal infiltrates, and corneal melting; the submit your manuscript | www.dovepress.com Clinical Ophthalmology 2016:10 385–391 385 Dovepress © 2016 Kawahara et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you http://dx.doi.org/10.2147/OPTH.S101836 hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Kawahara et al Dovepress complications of NSAIDs are considerably less frequent classification. The preoperative inclusion criteria were as than those of steroids.5 By inhibiting COX activity in the follows: 1) a transparent cornea, 2) no dry eye, blepharitis arachidonic acid cascade, NSAIDs decrease prostaglandin or associated lid diseases, glaucoma, or retinal disease, and synthesis. Prostaglandins are essential for protein and DNA 3) no history of ocular injury or surgery. The postoperative synthesis in epidermal cells; therefore, postoperative use exclusion criteria included perioperative and postoperative of NSAIDs may affect corneal epithelial wound healing.6,7 complications within the follow-up period. Patients who In particular, diclofenac sodium significantly delayed failed to attend postoperative appointments and who dosed early wound healing in scraped rabbit corneal epithelium the study medication improperly were also excluded. and reepithelialization after penetrating keratoplasty.7 Patients were randomly divided into two groups accord- Nepafenac has a unique prodrug structure compared with ing to the prescribed NSAID (nepafenac or diclofenac other topical NSAID eye drops, allowing a rapid penetration ophthalmic solutions) using a computer-generated stratified through the cornea to ultimately reach the anterior chamber random allocation. All patients were instructed to stop the and posterior segment of the eye.8–10 In the aqueous humor, use of all ophthalmic solutions for at least 2 weeks prior to nepafenac is converted to amfenac, a potent NSAID.8 It surgery, although 32 patients used pirenoxine (Kary Uni; may be possible that corneal damage after cataract surgery Santen Pharmaceutical, Osaka, Japan) and 9 patients used would be milder with the use of nepafenac rather than cyanocobalamin (Sancoba; Santen Pharmaceutical) when diclofenac sodium. they approved participation to the clinical research. Patients The main objective of our study was to compare the received levofloxacin (Cravit; Santen Pharmaceutical) effects of nepafenac ophthalmic suspension 0.1% (Nevanac; three times daily into their operated eye beginning 3 days Alcon, Tokyo, Japan) and diclofenac sodium ophthalmic preoperatively. On the day of surgery, patients received an solution 0.1% (Diclod; Wakamoto, Tokyo, Japan) on the NSAID (nepafenac or diclofenac) hourly for three doses in cornea, tear film, and ocular surface after cataract surgery. To their operated eye beginning 3 hours before surgery. For the best of our knowledge, this is the first randomized study pupillary dilation, all patients received two drops each of For personal use only. comparing the safety of nepafenac and diclofenac sodium tropicamide (Mydrin-P; Santen Pharmaceutical) and phe- eye drops on ocular surface after cataract surgery. nylephrine hydrochloride (Neosynesin; Kowa, Nagoya, Japan) into their operated eye every 10 minutes for four Materials and methods doses beginning 1 hour before surgery. Ofloxacin ointment Trial registration (Tarivid ophthalmic ointment; Santen Pharmaceutical) was UMIN000017667; May 25, 2015. instilled beneath a sterile monocular patch at the end of surgery. During surgery, the patients received no topical, Study design systemic, or subconjunctival anti-inflammatory medica- This was a prospective, randomized, parallel-group study tion. The patients received no other medication for the first Clinical Ophthalmology downloaded from https://www.dovepress.com/ by 54.70.40.11 on 27-Dec-2018 designed to evaluate the effects of nepafenac and diclofenac 24 hours and returned to the office on the first postoperative ophthalmic solutions on the cornea at 4 weeks after cataract day. After the removal of their dressing and the first postop- surgery in patients. The study consisted of five visits, which erative examinations, the postoperative therapy was started. included the inspection before surgery and the screening The postoperative therapy included a topical combination of visit, the cataract surgery visit (day 0), and three postopera- levofloxacin, betamethasone (Linolosal; Wakamoto), and an tive follow-up visits (on days 1, 7, and 28). The institutional NSAID three times a day for 1 week, followed by an NSAID review board of the Sapporo Tokushukai Hospital approved alone three times a day for an additional 3 weeks. this study, which adhered to the tenets of the Declaration All surgeries were performed by a single, experienced of Helsinki. All patients provided informed consent after surgeon (AK) by using the same phaco machine (Infiniti receiving an explanation of the nature and possible conse- Vision System with OZil Intelligent Phaco Torsional quences of the study. Technology; Alcon). After topical anesthesia with 4% We included consecutive patients undergoing routine lidocaine hydrochloride, a 2.4 mm transconjunctival single- uniocular cataract surgery at the Department of Ophthal- plane sclerocorneal incision11 was created at the 12 o’clock mology, Sapporo Tokushukai
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