Loteprednol Etabonate Postoperative Inflammation Study Group 2. Donnenfeld said he continues NSAIDs for 4 weeks postoperatively in his cataract patients but may extend NSAID use to 2 or 3 months for patients who experience extreme inflammation or those with inflammatory diseases, uveitis or diabetes. It is likewise true that eye medications (drops) she would use after a surgery like that or to treat her eye pressure and inflammation can cause pupil size modifications and ptosis, so once again, essential concerns for the surgeon/treating physician. Even though NSAIDs work by inhibiting prostaglandin production, they do not influence preformed prostaglandin, according to Donnenfeld. “A Beverly Hills cataract is removed pretty easily because the modest nuclear sclerosis means that it’s not dense. Injectable steroids under the conjunctiva, such as subconjunctival dexamethasone or a sub-Tenon’s injection of triamcinolone, or intracamerally with appropriate medications can result in a better anti-inflammatory response after cataract surgery, according to Devgan. Results were limited to English-language, peer-reviewed primary studies and reviews published between the years 2000 and 2010 (inclusive). “From a comfort standpoint, we consider it a significant advantage to have an office facility in which we can perform vision correction surgery with refractive IOLs. Corticosteroids act to reduce inflammation at multiple points in the inflammatory cascade (see Table 1 and Figure 1), including both the cyclo-oxygenase pathway and the lipoxygenase pathway through inhibition of phospholipase A2, producing a reduction in both prostaglandins and leukotrienes.11, While the long-term use of corticosteroids may be associated with side effects such as elevated IOP, onset of glaucoma, aggravation of other disease states (including viral or fungal keratitis), cataract and a delay in the normal course of wound healing,33–35 the two- to six-week course of ophthalmic corticosteroid treatment following cataract surgery is generally effective yet short enough, sometimes, to avoid these concerns.11,12 However, the ability of certain topically administered corticosteroids to raise lOP, particularly in open-angle glaucoma patients, limits the usefulness of these potent anti-inflammatory agents.34 The propensity of corticosteroids to induce ocular adverse effects may also vary depending on whether or not the patient is a steroid responder.33,36,37 Table 2 presents the average increase in IOP for different corticosteroids in steroid-sensitive patients. I want to keep pace with innovation, new techniques and new technologies, but if you’re going to come out with a new product that’s hundreds of dollars, I have to ask myself, does that patient really need it or is there another alternative that’s better or just as good? Jonas JB, Kreissig I, Spandau UH, Harder B, Infectious and noninfectious endophthalmitis after intravitreal high-dosage triamcinolone acetonide. Nonsteroidal antiinflammatory drugs (NSAIDs) have become an important adjunctive tool for surgeons performing routine and complicated cataract surgery. Dextenza’s approval is another positive addition to a surgeon’s armamentarium to limit pain and inflammation after cataract surgery. To avoid ocular surface irritation and dryness in the early postoperative period, we avoid [balanced salt solution] irrigation of the eye and instead, at the beginning of the treatment, place a dispersive viscoelastic such as hydroxypropyl methylcellulose on the ocular surface for patient comfort,” Brinton said. PREOPERATIVE NONSTEROIDAL ANTI-INFLAMMATORY DRUG USE. The assessment of cells did not differ among the treatments (p=0.165). Current standard-of-care for inflammation follow cataract surgery involves self-administering medicated eye-drops for a period of weeks. These claims have not been verified by the U.S. Food and Drug Administration. Your surgical wound will probably be covered with a bandage after the operation, but some doctors will apply a compression bandage for areas especially prone to inflammation. In some cases, the anti-inflammatory eye drops will need to be used longer than that. We consider pain and inflammation as being extremely important in our patients,” Donnenfeld said. 11 Compared with NSAIDs, corticosteroids have a wider range of activity in relieving inflammation (see Figure 1 ). I’m very excited about the new drug delivery platforms, either punctal plug drug delivery or intracameral drug delivery. There are a variety of topical steroids available, and each has its own benefits. Corticosteroids are effective, but NSAIDs may provide an additional benefit to reduce inflammation when given in combination with corticosteroids. Ocular inflammation after cataract surgery presents healthcare providers with a treatment dilemma. Some are choosing to use fewer drops, while others are choosing to forego topical medications altogether and inject medications instead. Patients want to hear the doctor’s voice and want staff to tell them what to expect next through the process. Dexycu (dexamethasone intraocular suspension) 9% is an extended-release steroid that replaces eye drops after cataract surgery with a single shot. Loteprednol Allergic Conjunctivitis Study Group. Schacke H, Docke WD, Asadullah K, Mechanisms involved in the side effects of glucocorticoids. In other studies, LE was comparable with other corticosteroids in the effective reduction of inflammation following cataract surgery.46,48. Stern GA, Factors affecting the efficacy of antibiotics in the treatment of experimental postoperative endophthalmitis. Infectious and non-infectious aetiologies of ocular inflammation are treated differently.29 Infectious complications, such as post-operative endophthalmitis, may occur during any ocular surgical procedure.30,31 Common post-operative endophthalmitis infections are often caused by the entry into the intraocular space of bacteria that normally inhabit the lid and conjunctiva.32 Prevention with appropriate pre- and post-surgical antibiotics reduces the incidence of endophthalmitis and inflammation.30 Corticosteroids are often used in combination with antibiotics to treat inflammation due to endophthalmitis.30, There are no established treatment guidelines to prevent or reduce inflammation following ocular surgery.8,11 Therefore, treatment includes pre- and post-operative anti-inflammatory therapies such as corticosteroids and NSAIDs (see Table 1).8,11,23 Since it is impossible to predict which patients will develop clinically significant post-operative inflammation, anti-inflammatory agents are routinely used post-operatively.3,8,20,21 In some institutions, especially those in the UK, corticosteroids are the preferred option.3, Corticosteroids are traditionally used for short-term control of ocular inflammation33 and are a mainstay of treatment regimens following cataract surgery.11 Compared with NSAIDs, corticosteroids have a wider range of activity in relieving inflammation (see Figure 1). Treatment with peri-operative ketorolac and post-operative prednisolone acetate significantly reduced the incidence of both CMO and macular thickening in cataract surgery patients, indicating that the combination of a corticosteroid and an NSAID was synergistic in the prevention of inflammation following surgery.64 Similarly, treatment with diclofenac for two days pre-operatively and four weeks post-operatively plus steroid post-operatively reduced the incidence of CMO in a study of 60 patients undergoing small-incision cataract surgery as compared with treatment with diclofenac and steroid post-operatively only. J Cataract Refract Surg 2003;29:2:250-256. When using a steroid and NSAID in combination, it is possible to use a topical steroid at a lower frequency per day as compared with using a topical steroid without an NSAID, OSN Technology Section Editor William B. Trattler, MD, said. You know your patient and your population, your nuances, better than everyone else. Missotten L, Richard C, Trinquand C, Topical 0.1% indomethacin solution versus topical 0.1% dexamethasone solution in the prevention of inflammation following cataract surgery. Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros) is the only FDA-approved intracameral NSAID-containing injection that reduces inflammation and maintains mydriasis, according to Farid. Interestingly, there are no studies showing that antibiotic eye drops decrease the infection rate. The more you manipulate the iris, the more postop inflammation you’ll see. Scientific Department, The Royal College of Ophthalmologists, London, 2004. Loteprednol Etabonate Giant Papillary Conjunctivitis Study Group I. Ilyas H, Slonim CB, Braswell GR, et al., Long-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitis. There is no medical treatment for cataracts.2,3 Non-surgical management of cataract includes counselling and use of spectacles or low-vision aids.6,8 Surgical removal of cataract remains the only treatment option for patients with failing vision.3 Cataract surgery is the most commonly performed surgical operation in the Western world.2,9 Small-incision cataract surgery using phacoemulsification has largely replaced extracapsular cataract extraction because of faster healing, smaller wounds and fewer resultant complications,3,6,8 with improved patient outcomes.10 However, post-operative complications, including ocular inflammation after cataract surgery, continue to cause visual impairment, pain and other sequelae among patients. Dell SJ, Lowry GM, Northcutt JA, et al., A randomized, double-masked, placebo-controlled parallel study of 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis. Available at: www.rcophth.ac.uk/documents.asp?section=39& sectionTitle=Publications&page=9 (accessed 4 April 2012). To determine whether you have a cataract, your doctor will review your medical history and symptoms, and perform an eye examination. Acknowledgement: The authors thank The Scienomics Group for editorial assistance. Ice packs may help reduce inflammation after surgery. “When you’re doing the procedure, be very efficient in the eye. Therefore, pretreatment with an NSAID is an important step in a surgeon’s protocol to limit postoperative pain. Rowen S, Preoperative and postoperative medications used for cataract surgery. Bromfenac and nepafenac are both excellent NSAIDs. This limitation of traditional corticosteroids led to the development of C-20 ester corticosteroids through retrometabolic drug design. The laser has been shown to reduce the total amount of energy required to emulsify the nucleus during surgery,” he said. For patients with minor swelling, Durezol may not be necessary. Nevanac is used to reduce pain and swelling after cataract surgery. Ketorolac ophthalmic may also be used for purposes not listed in this medication guide. “Pain and inflammation are two of the more important concepts we need to embrace and manage for patients undergoing ophthalmic surgery,” he said. If you’re an experienced surgeon, you can be very efficient and minimize the phaco energy by using the phaco chop technique, as well as phaco power modulation. “Use of good topical analgesics intraoperatively will also aid with immediate postoperative discomfort,” she said. The three primary classes of medications used around the time of cataract surgery are antibiotics, corticosteroids and nonsteroidal anti-inflammatory drugs … Ophthalmologists and patients have different views about what constitutes a successful cataract surgery. If you are experiencing inflammation after your cataract surgery, your ophthalmologist will likely prescribe you eyedrops. Relevant publications were identified through searches of PubMed, Embase and the Cochrane Library using the following search terms: cataract, cataract surgery, postsurgical inflammation, anti-inflammatory and corticosteroid. A double-masked placebo-controlled study. Patients dosed either once a day or twice a day for a median of 27.1 days experienced reduced inflammation compared with patients treated with prednisolone acetate. Simone J, Pendelton R, Jenkins J, Comparison of the efficacy and safety of ketorolac tromethamine 0.5% and prednisolone acetate 1% after cataract surgery. Pavesio CE, Decory HH, Treatment of ocular inflammatory conditions with loteprednol etabonate. Inveltys (loteprednol etabonate ophthalmic suspension 1%, Kala Pharmaceuticals) is an effective, safe steroid to treat inflammation after cataract surgery, and it … In contrast, corticosteroid therapy (prednisolone acetate) was markedly effective, both when used after the induction of inflammation and when initiated 48 hours previously. Can I just inject steroid conjunctival or sub-Tenon’s and have the same effect or a better effect?”. Stewart R, Horwitz B, Howes J, et al., Double-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% for postoperative inflammation. BromSite was approved by the FDA in 2016 to prevent pain and treat inflammation in cataract surgery and is delivered via the DuraSite vehicle, which is a polymer-based formulation that increases the drug’s residence time on the ocular surface. Normally, the lens of your eye is clear. After a couple of days, most of the discomfort should disappear. Cataract surgery usually goes well, but it helps to know what to look out for. Because LE has been shown to have a better safety profile in the control of inflammation following cataract surgery compared with prednisolone and other C-20 ketone corticosteroids, it may be a better option when used in combination with an NSAID. Both drugs were well tolerated but conjunctival hyperaemia was less pronounced in the dexamethasone group on post-operative day 30 (p=0.046). In a recent review, bromfenac twice daily (BID) was found to demonstrate an early and sustained level of clinical activity with little burning and stinging and minimal adverse events in the treatment of ocular inflammation following cataract surgery.56 Preclinical studies with bromfenac demonstrated that the addition of bromine increased ocular penetration, suggesting that bromfenac BID may be as potent as other NSAIDs administered more frequently but with less potential for corneal toxicity. The medications can cost as much as $200 each, he said. Shulman DG, Lothringer LL, Rubin JM, et al., A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis. Intraoperatively, I make sure that the ocular surface is well lubricated to minimize postoperative punctate keratitis from dryness. In two similar clinical trials evaluating the use of LE for treating post-cataract inflammation, LE produced significantly lower rates of treatment-emergent adverse events compared with placebo (p<0.001 in study 1 and p=0.002 in study 2).20,21 There was no significant difference in mean change in IOP with LE compared with placebo and no evidence of deleterious effects on post-operative recovery.20,21 LE had a smaller impact on IOP increase than prednisolone acetate when these corticosteroids were compared in patients undergoing cataract surgery.46 Long-term (≥28 days) administration of either LE 0.2 or 0.5 % was associated with a low incidence of elevated IOP, which was comparable with placebo and lower than the rate observed with prednisolone acetate 1.0 %.47 LE (0.2 %) has reportedly been used for up to three years in patients with allergic conjunctivitis without inducing clinically significant elevated IOP (p=0.824).44, Post-operative corticosteroid treatment results in a reduced presence of inflammatory cells and flare within the anterior chamber compared with placebo.22–25 In the above clinical trials, LE was more effective than placebo in reducing anterior chamber cells and flare when used after cataract surgery in patients with a cumulative inflammation severity of at least grade 3 (on a scale of 0–9).20,21 A significantly greater proportion of LE-treated patients versus patients taking placebo achieved complete resolution of anterior chamber cells and flare (p<0.001 for both studies).20,21 By the final visit, 93 and 89 % of LE-treated patients compared with 65 and 64 % of vehicle-treated patients, respectively, had mild or resolved anterior chamber inflammation in each study.20,21 Reduction in severity for both cells and flare individually, on average, was greater in the LE group compared with the placebo group (see Figures 3 and 4; p<0.001 for both end points in both studies).20,21 There was no indication of rebound inflammation following the cessation of LE therapy. Lotemax gel, a topical corticosteroid, was FDA approved in 2012 for the treatment of postoperative inflammation and pain after ocular surgery. Sun R, Gimbel HV, Effects of topical ketorolac and diclofenac on normal corneal sensation. Cost needs to be considered when deciding on a protocol to manage pain and inflammation. On the day of surgery, Farid gives patients topical proparacaine eye drops before dilation, as well as topical TetraVisc (tetracaine 0.5%, OcuSoft) to manage intraoperative pain. You must tailor your treatment to your patient. She graduated in pharmacology and statistics (MSc) and completed her PhD thesis in anatomy. The three most typical postoperative classes of medication — antibiotic, steroid and NSAID — can cost more than the surgeon’s fee for cataract surgery if they are the retail brand name medications, Devgan said. The more fluid you run through the eye, the more inflammation you’ll have postop. Antibiotic eyedrops are used after cataract surgery to prevent infection and steroid and NSAID (non-steroidal anti-inflammatory drug) eyedrops are used to reduce and remove inflammation. Dextenza demonstrated efficacy in two randomized, vehicle-controlled phase 3 studies in which a statistically significant number of patients who received the insert were free of pain 8 days after cataract surgery compared with patients in the vehicle control group. “It could eliminate the need for topical or clinical steroids in most patients after cataract surgery,” Donnenfeld said. NSAIDs are cyclo-oxygenase inhibitors that work by suppressing production of prostaglandins. Brinton JP, et al. This allows LE to be active at the glucocorticoid receptor, its site of action, and subsequently to undergo predictable hydrolysis to inactive carboxylic acid metabolites by naturally occurring ocular esterases. Drug delivery systems are the future of pharmaceuticals in ophthalmology,” he said. Also, microscopic remnants of the cataract are often left in the anterior chamber of the eye, which lead to continued release of inflammatory factors. Patients are more comfortable having already become familiar with our office staff and environment, as opposed to having to go to a hospital or ambulatory surgical center,” he said. The efficacy of ketorolac tromethamine 0.5 % was compared with LE (0.5 %) in controlling inflammation after cataract surgery in 60 patients pre-operatively and one, three, seven and 30 ± 7 days post-operatively.57 There was no statistically significant difference in post-operative inflammation (objective or subjective cell and flare measurements) or IOP between the two groups.57 A prospective randomised double-masked study compared ketorolac tromethamine (0.5 %) with prednisolone acetate (1 %) in controlling inflammation after cataract surgery in 59 patients for 28 days. Pain is an important concept of patients having surgery. The best control of surface inflammation and highest patient comfort were achieved with prednisolone (p=0.041).62, Because NSAIDs and corticosteroids have different mechanisms of action, they may be synergistic in the prevention and treatment of ocular inflammation after cataract surgery. Prolensa™ (bromfenacophthalmic solution) is a prescription medication used to reduce inflammation and pain after cataract surgery. After cataract surgery, the risk of eye inflammation lasts longer than the risk of eye infection. Inflammation is usually treated with steroids or non-steroidal anti-inflammatory drugs (NSAIDs). Patient communication during cataract surgery. Laurell CG, Zetterstrom C, Effects of dexamethasone, diclofenac, or placebo on the inflammatory response after cataract surgery. Your eyes are tested one at a time, while the other eye is covered. Harminder Dua, Division of Ophthalmology and Visual Sciences, B Floor, Eye, Ear, Nose and Throat Centre, University Hospital, Nottingham NG7 2UH, UK. Flach AJ, Cyclo-oxygenase inhibitors in ophthalmology. Findl O, Redefining the Treatment Paradigm for Post-operative Inflammation Control –The Role of Topical Non-steroidal Anti-inflammatory Drugs. Brinton operates and examines patients in an office facility, an environment that is more conducive to patient comfort than an operating room, he said. Bromfenac 0.075% in the DuraSite™ vehicle is a newly-approved formulation which has been shown to be efficacious and safe for use in cataract Colin J, The role of NSAIDs in the management of postoperative ophthalmic inflammation. We allow patients to listen to the music of their choice and, with certain guidelines, allow family members to suit up and sit next to their loved one, holding their hand during the treatment,” he said. Mike: I also have pain 2 years later. In the charity clinic with my UCLA residents, this is the home of the brunescent and white cataract. Antibiotic Medication Antibiotic treaments are routinely administered after cataract surgery for the first few weeks. Chang DF, Garcia IH, Hunkeler JD, Minas T, Phase II results of an intraocular steroid delivery system for cataract surgery. “It makes you wonder, is there a role for lower costs? Solomon KD, Vroman DT, Barker D, Gehlken J, Comparison of ketorolac tromethamine 0.5% and rimexolone 1% to control inflammation after cataract extraction. Ketorolac was as effective and well tolerated as prednisolone in controlling post-operative inflammation and pain after cataract surgery.58 Ketorolac tromethamine (0.5 %) and rimexolone 1 % were compared for controlling post-operative inflammation in 36 patients that had undergone cataract surgery; there were no statistically significant differences between the groups in cells, flare or IOP.59 Dextenza has completed Phase 3 evaluation for the treatment of ocular pain and inflammation following ophthalmic surgery, but is currently limited to investigational use only. obtained serial 100 μl samples of aqueous humor in 12 patients undergoing cataract surgery. Henderson B, Kim J, Ament C, et al., Clinical pseudophakic cystoid macular edema- Risk factors for development and duration after treatment. Mati Therapeutics announced interim phase 2 clinical trial results evaluating the efficacy of nepafenac delivered via sustained ocular drug delivery platform. Colin J. Asano S, Miyake K, Ota I, et al., Reducing angiographic cystoid macular edema and blood-aqueous barrier disruption after small-incision phacoemulsification and foldable intraocular lens implantation: multicenter prospective randomized comparison of topical diclofenac 0.1 % and betamethasone 0.1 %. 5. Baltussen R, Sylla M, Mariotti S, Cost-effectiveness analysis of cataract surgery: a global and regional analysis. A patient who is familiar with the operating environment, the surgeon and the clinic staff can be more at ease during a procedure and experience less discomfort postoperatively, Brinton said. Not all patient populations are the same, not all cataracts are the same, and not all surgeons have the same experience. Novack GD, Howes J, Crockett RS, Sherwood MB, Change in intraocular pressure during long-term use of loteprednol etabonate. Mean IOP was statistically significantly higher in dexamethasone-treated patients.22 Comparison of diclofenac 0.1 % and betamethasone 0.1 % in preventing CMO and BAB disruption after small-incision cataract surgery demonstrated a lower incidence of fluorescein angiographic CMO in the diclofenac group (18.8 %) than in the betamethasone group (58.0 %) (n=150, p<0.001).61 There was significantly less anterior chamber flare in the diclofenac group than in the betamethasone group (p<0.05) at one and two weeks, while IOP was significantly higher in the betamethasone group at eight weeks (p=0.0003).61 Surface inflammation and patient comfort were not assessed in this study.61 Mentes J, Erakgun T, Afrashi F, Kerci G, Incidence of cystoid macular edema after uncomplicated phacoemulsification. 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