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6 Currently 2,3 > .001). Anterior .001). > P but topical dexametha topical but 4,5 > .001). Adverse events were eventsAdverse .001). > P The appropriate postoperative appropriate The therapy topical make issues Many Anterior chamber cell clearing at clearing cell chamber Anterior surgery. Poor compliance is a major a is compliance Poor surgery. to unable are patients Many issue. consistent a in drops administer know to difficult it making manner, eye. the reaching actually is what is medications of cost high The for dosing proper to obstacle another adverse Additionally, patients. some allergic and spikes IOP as such events 66% in group 3 ( 3 group in 66% was 8 day at clearing flare chamber 1, group in eyes of 63.8% in achieved group in 89.1% and 2, group in 92.4% ( 3 with groups three the among similar up reported events adverse serious no 90. day postoperative to DISCUSSION surgery for regimen medical The subject. debated hotly a remains in and alone steroids topical of use the be to continues combination managing of mainstay surgery. after and topical FDA-approved only the postoperative for corticosteroids and difluprednate are inflammation rimexolone, are acetate prednisolone and sone off-label. used commonly treatment the for problematic cataract after inflammation of day 8 was achieved in 25% of eyes of 25% in achieved was 8 day and 2, group in 63% 1, group in The primary outcome measure outcome primary The after surgery. after clearing cell chamber anterior was Secondary 8. day postoperative at flare chamber anterior were measures flare plus cell chamber anterior and Adverse eyes. study the in clearing assessed. also were events ninety-four patients scheduled for scheduled patients ninety-four siteswere 27 at surgery cataract groups. three to assigned randomly of injection 5-µL a received 1 Group respectively, 3, and 2 Groups placebo. or µg 342 of injection 5-µL a received delivery drug dexamethasone µg 517 chamber anterior the into suspension surgery. cataract of conclusion the at days 90 for observed were Patients

- Closing in on no-drop surgery. Closing in on no-drop MS MD; AND KENDALL E. DONALDSON, MD, BY MARK A. KONTOS, | JULY 2019 | JULY

1

. This large multicenter randomized controlled study found that a a study found that controlled surgery. This large multicenter randomized cataract of the drug was a safe and effective alternative to topical slow-release delivery system therapy after cataract surgery. steroid formulation of intracameral dexamethasone for the treatment of inflammation after the treatment of inflammation after formulation of intracameral dexamethasone for A phase 3 clinical trial was designed to determine the safety and efficacy of a novel efficacy of a novel to determine the safety and designed A phase 3 clinical trial was 

s surgery of cataract a steroid at the time of administering a single dose possibility of The

and eliminating postoperative eye drops could offer significant advantages to both surgeons offer significant advantages to both surgeons and eliminating postoperative eye drops could of dexamethasone on this study’s results, a slow-release delivery system and patients. Based forms of and other this system reality. Direct comparisons of possibility a may help make that treatment are needed. WHY IT MATTERS STUDY IN BRIEF In this randomized, double-masked, double-masked, randomized, this In intraocular suspension 9% (Dexycu, 9% suspension intraocular for Pharmaceuticals) EyePoint in administration intracameral undergoing patients in dosages two hundred Three surgery. cataract ABSTRACT SUMMARY inves study, placebo-controlled the determine to sought tigators dexamethasone of efficacy and safety DEXAMETHASONE INTRACAMERAL DEXAMETHASONE INTRACAMERAL DRUG-DELIVERY SUSPENSION FOR INFLAMMATION ASSOCIATED WITH CATARACT SURGERY: A RANDOMIZED, PLACEBO-CONTROLLED PHASE III TRIAL Donnenfeld E, Holland E

CATARACT SURGERY CATARACT INTRACAMERAL THERAPEUTICS FOR FOR THERAPEUTICS INTRACAMERAL CATARACT & REFRACTIVE SURGERY TODAY

18 s THE LITERATURE THE LITERATURE s

reactions make topical therapy through surface tension in the at all endpoints. It was also noted less than ideal for the treatment anterior chamber and slowly releases that these patients showed better of postoperative inflammation. dexamethasone over a 21-day clearing of the anterior chamber at Eliminating the need for eye drops period. Concentrations are highest day 8 than is commonly observed after cataract surgery could thus offer on day 1 and steadily decrease with current topical steroid many advantages. thereafter. Patients receiving therapies.8 In addition to meeting This study found that intracameral intracameral dexamethasone showed efficacy endpoints, intracameral delivery of dexamethasone in a significantly greater clearing of cell dexamethasone was shown to be slow-release form can be an effective and flare of the anterior chamber safe, with no significant adverse alternative to topical therapy. The compared to the placebo group. This events noted during the 90-day injected 5-µL droplet forms a sphere difference was statistically significant period of observation.

SAFETY AND EFFICACY OF INTRACAMERAL MOXIFLOXACIN FOR PREVENTION OF POST-CATARACT STUDY IN BRIEF : RANDOMIZED CONTROLLED CLINICAL TRIAL s This is the first large prospective randomized controlled clinical trial to evaluate the safety and efficacy of intracameral moxifloxacin for the postoperative prevention of Melega MV, Alves M, Cavalcanti Lira RP, endophthalmitis associated with cataract surgery. et al9 WHY IT MATTERS ABSTRACT SUMMARY Intracameral appear to be a safe and effective means of protecting patients from This controlled, randomized, the rare incidence of infection that may be associated with cataract surgery. single-center (including three hospitals associated with the University of Campinas in São Paulo, Brazil) clinical trial comprised 3,640 eyes of overwhelming efficacy of intracameral an eye in rare instances.14-16 Limited 3,640 patients undergoing cataract antibiotics, this practice has gained availability of intracameral antibiotics surgery. Patients were randomly widespread attention.10-13 The globally has prompted many surgeons assigned to one of two groups: one ESCRS investigators reported a to prepare drugs in the OR, which group received an intracameral fivefold decrease in the incidence has led to errors that have resulted injection of 0.03 mL (150 µg) of of endophthalmitis associated with in clinical manifestations such as undiluted moxifloxacin at the end of intracameral cefuroxime, resulting macular , retinal vascular surgery, and the other received no in the commercial manufacture of a leakage, , endothelial toxicity, intracameral injection. All patients single-use preparation of this agent toxic anterior segment syndrome, and received postoperative and labeled for intraocular use (Aprokam, infection.14-16 antiinflammatory drops (0.5% moxi- Laboratoires Théa) that quickly Moxifloxacin is a fourth-generation floxacin and 0.1% dexamethasone). became available for use in Europe and fluoroquinolone that provides Patients were observed for a period elsewhere in the world but not in the broad-spectrum coverage against of 6 weeks postoperatively. During this United States.10 gram-positive bacteria, gram-negative time, the incidence of endophthalmitis This country has faced challenges bacteria, atypical microorganisms, was 0.05% (1:1,818 eyes) in the moxi- related to implementation of such and anaerobes. Concern is rising floxacin group and 0.38% (7:1,822 eyes) a regimen, including issues related about increasing drug resistance, in the control group (P = .202). No to the safety of compounding however, because of moxifloxacin’s side effects related to intracameral medications for intraocular use.14-16 popularity.17 The agent has been moxifloxacin were observed during There have been documented cases used off-label for the prevention of the study. of compounding errors, including endophthalmitis for many years, but dilutional mistakes, pH imbalance, only recently has attention begun to DISCUSSION contamination, and other deviations focus on conducting controlled trials Since the 2007 publication of that have led to profound vision loss to better elucidate the drug’s efficacy ESCRS study results indicating an in some patients and even loss of for endophthalmitis prophylaxis.

JULY 2019 | CATARACT & REFRACTIVE SURGERY TODAY 19

Editorial Advisory Board Executive Advisory Board CRST CRST Financial disclosure: Consultant (Allergan, Financial disclosure: Consultant (Allergan, Professor of Clinical Ophthalmology, Ophthalmology, Professor of Clinical Member, [email protected] Financial disclosure: Consultant Senior Partner, Empire Eye Physicians, [email protected] Carl Zeiss Meditec, EyePoint Pharmaceuticals, Carl Zeiss Meditec, EyePoint Pharmaceuticals, Johnson & Johnson Vision, Omeros, Shire, Sun Pharmaceutical) /external disease/refractive surgeon, and and disease/refractive surgeon, Cornea/external Eye Institute, Medical Director, Bascom Palmer Plantation, Florida Lomb, Bio-Tissue, (Alcon, Allergan, Bausch + Pharmaceuticals, Carl Zeiss Meditec, Eyevance Quidel, Kala Pharmaceuticals, Lumenis, Sun Pharmaceutical, Takeda) Spokane, Washington, and Coeur d’Alene and Hayden, Idaho Member,     KENDALL E. DONALDSON, MD, MS MD, MS KENDALL E. DONALDSON, n n n n n MARK A. KONTOS, MD n n n . . J Cataract Cochrane Database Acta Ophthalmol Acta Ophthalmol . 2018;102(9):1268- . 2017;135(7):814-815. Br J Ophthalmol . 2006;32(2):324-333. JAMA Ophthalmol EDWARD MANCHE, MD . 2007;33(6):978-988. . 2007;33(6):978-988. . 2011;37(2):271-278. J Cataract Refract Surg . 2017;2:CD006364. Director of Cornea and Refractive Surgery, Director of Cornea and Refractive Surgery, Professor of Ophthalmology, Stanford University [email protected] Financial disclosure: None Stanford Laser Eye Center, California School of Medicine, California    12. Kessel L, Flesner P, Andresen J, et al. Antibiotic prevention of postcataract 12. Kessel L, Flesner P, Andresen J, et al. meta-analysis. endophthalmitis: a systematic review and Refract Surg DG, et al. Toxic anterior segment 16. Mamalis N, Edelhauser HF, Dawson syndrome. 17. Stringham JD, Relhan N, Miller D, Flynn HW Jr. Trends in fluoroquinolone nonsusceptibility among coagulase-negative Staphylococcus isolates causing endophthalmitis, 1995-2016. SECTION EDITOR n n n n 10. Endophthalmitis Study Group, European Society of Cataract & Refractive Study Group, European Society of Cataract 10. Endophthalmitis cataract of postoperative endophthalmitis following Surgeons. Prophylaxis of risk factors. ESCRS multicenter study and identification surgery: results of the J Cataract Refract Surg for K, Tulenko SE, et al. Perioperative antibiotics 11. Gower EW, Lindsley cataract surgery. prevention of acute endophthalmitis after Syst Rev 2015;93(4):303-317. et al. Comparative analysis of the safety 13. Bowen RC, Zhou AX, Bondalapati S, moxifloxacin and vancomycin at the and efficacy of intracameral cefuroxime, end of cataract surgery: a meta-analysis. 1276. because of inaccurate preparation 14. Olavi P. Ocular toxicity in cataract surgery cefuroxime. and erroneous use of 50mg/ml intracameral 2012;90(2):e153-154 al. Ocular toxicity after intracameral 15. Delyfer MN, Rougier MB, Leoni S, et during cataract surgery. injection of very high doses of cefuroxime - . 2007;105:29-33. . 2003;217(6):408- . 2019;45(3):343- . 2018;125(6):799-806. n Ophthalmologica . 2000;11(1):3-6. J Cataract Refract Surg Trans Am Ophthalmol Soc Ophthalmology . 2014;8:1281-1289. Clin Ophthalmol Curr Opin Ophthalmol As cataract surgery evolves and evolves surgery cataract As intracameral moxifloxacin for prevention of post-cataract endophthalmitis: randomized controlled clinical trial. 350. 6. Grob SR, Gonzalez-Gonzalez LA, Daly MK. Management of and pain in cataract and intraocular surgery: review of current medications and future directions. 7. Tsai T, Robin AL, Smith JP 3rd. An evaluation of how patients use topical medications: a pilot study. 8. Kurt E, Mayali H. Early post-operative complications in cataract surgery. IntechOpen. http://scholar.google.com/scholar_url?url=https://www. intechopen.com/download/pdf/42708&hl=en&sa=X&scisig=AAGBfm1XmS Zs3O6wGg2SAn3jDfkKbPleIQ&nossl=1&oi=scholarr. Accessed May 14, 2019. 9. Melega MV, Alves M, Cavalcanti Lira RP, et al. Safety and efficacy of 1. Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery 1. Donnenfeld E, Holland E. Dexamethasone with cataract surgery: a randomized, suspension for inflammation associated placebo-controlled phase III trial. inflammation associated with 2. McColgin AZ, Heier JS. Control of intraocular cataract surgery. Incidence cystoid 3. Mentes J, Erakgun T, Afrashi F, Kerci G. after uncomplicated phacoemulsification. 412. 4. Vexol [package insert]. Fort Worth, TX: Alcon Pharmaceuticals; 2012. 5. Durezol [package insert]. Fort Worth, TX: Alcon Pharmaceuticals; 2017. office-based, no-drop surgery grows, surgery no-drop office-based, eventu may antibiotics intracameral Unitedthe In necessity. a become ally anddelivery controlled the States, medicationsthese of manufacturing fine-tuned. being are interest in bilateral, same-day, bilateral, in interest

s THE LITERATURE