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      Clinical outcomes after injection of a compounded pharmaceutical for prophylaxis after cataract surgery: a large-scale review

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          Abstract

          Purpose of review

          To evaluate relevant clinical outcomes following a transzonular intravitreal injection of a compounded triamcinolone–moxifloxacin–vancomycin (TMV) formulation for postoperative prophylaxis after cataract surgery in a retrospective review of medical records from a private practice, single-specialty ambulatory center in New Jersey, USA.

          Recent findings

          The analysis included 1541 cases from 922 patients who underwent cataract surgery with an intravitreal injection of TMV from November 2013 to December 2014. Cataract surgery was performed by a standard clear corneal phacoemulsification technique. Transzonular injection was used to deliver TMV directly into the anterior vitreous after implantation of an intraocular lens.

          Summary

          There were no major intraoperative complications associated with the transzonular injection technique. There were no cases of postoperative endophthalmitis. Nearly 92% of cases ( n = 1413/1541) did not require supplemental medication after surgery. The rate of breakthrough inflammation at Days 14–21 was 9.2% ( n = 132/1429). The rate of visually significant postoperative cystoid macular edema was 2.0% ( n = 28/1429). The rate of clinically significant postoperative intraocular pressure increase was low: 0.9% ( n = 13/1425) of cases had an at least 10 mmHg increase at Days 14–21 or 90. Four of these cases had intraocular pressure at least 30 mmHg. The rates of infection and inflammation reported in this retrospective review of a transzonular injection of TMV for prophylaxis after cataract surgery appear similar to reported rates with alternative prophylactic therapies such as topical drops. The transzonular injection of TMV may have advantages in terms of patient compliance.

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          Most cited references34

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          Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors.

          To identify risk factors and describe the effects of antibiotic prophylaxis on the incidence of postoperative endophthalmitis after cataract surgery based on analysis of the findings of the European Society of Cataract & Refractive Surgeons (ESCRS) multicenter study. Twenty-four ophthalmology units in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, Turkey, and the United Kingdom. A prospective randomized partially masked multicenter cataract surgery study recruited 16 603 patients. The study was based on a 2 x 2 factorial design, with intracameral cefuroxime and topical perioperative levofloxacin factors resulting in 4 treatment groups. The comparison of case and non-case data was performed using multivariable logistic regression analyses. Odds ratios (ORs) associated with treatment effects and other risk factors were estimated. Twenty-nine patients presented with endophthalmitis, of whom 20 were classified as having proven infective endophthalmitis. The absence of an intracameral cefuroxime prophylactic regimen at 1 mg in 0.1 mL normal saline was associated with a 4.92-fold increase (95% confidence interval [CI], 1.87-12.9) in the risk for total postoperative endophthalmitis. In addition, the use of clear corneal incisions (CCIs) compared to scleral tunnels was associated with a 5.88-fold increase (95% CI, 1.34-25.9) in risk and the use of silicone intraocular lens (IOL) optic material compared to acrylic with a 3.13-fold increase (95% CI, 1.47-6.67). The presence of surgical complications increased the risk for total endophthalmitis 4.95-fold (95% CI, 1.68-14.6), and more experienced surgeons were more likely to be associated with endophthalmitis cases. When considering only proven infective endophthalmitis cases, the absence of cefuroxime and the use of silicone IOL optic material were significantly associated with an increased risk, and there was evidence that men were more predisposed to infection (OR, 2.70; 95% CI, 1.07-6.8). Use of intracameral cefuroxime at the end of surgery reduced the occurrence of postoperative endophthalmitis. Additional risk factors associated with endophthalmitis after cataract surgery included CCIs and the use of silicone IOLs.
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            Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection.

            To describe the pharmacokinetics occurring after the direct injection of triamcinolone acetonide into the vitreous humor of humans. Interventional case series. Five patients who received a single 4-mg intravitreal injection of triamcinolone acetonide. An aqueous humor sample was obtained from 5 eyes via an anterior chamber paracentesis at days 1, 3, 10, 17, and 31 after injection. At each visit, visual acuity and intraocular pressure were measured and indirect ophthalmoscopy was performed. A fluorescein angiogram was carried out at day 10. Concentrations were determined using high performance liquid chromatography; pharmacokinetic analysis was carried out using PK Analyst, an iterative, nonlinear, weighted, least-squares regression program. Intraocular concentrations of triamcinolone were measured and population pharmacokinetic parameters were calculated. Pharmacokinetic data followed a two-compartment model. Peak aqueous humor concentrations ranged from 2151 to 7202 ng/ml, half-lives from 76 to 635 hours, and the integral of the area under the concentration-time curve (AUC(0-t)) from 231 to 1911 ng/h per milliliter. After a single intravitreal injection of triamcinolone, the mean elimination half-life was 18.6 days in nonvitrectomized patients. The half-life in a patient who had undergone a vitrectomy was shorter at 3.2 days. There was considerable intrasubject variation among peak concentration, AUC(0-t) values, and elimination half-lives. After intravitreal injection, measurable concentrations of triamcinolone would be expected to last for approximately 3 months (93 +/- 28 days) in the absence of a vitrectomy. Because triamcinolone pharmacokinetics were characterized only in elderly patients with macular edema, the results cannot be extrapolated to other patient populations.
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              Acute-onset endophthalmitis after cataract surgery (2000-2004): incidence, clinical settings, and visual acuity outcomes after treatment.

              To report the incidence, clinical settings, and visual acuity outcomes of acute-onset endophthalmitis after cataract surgery. Retrospective, observational case series. Annual cataract surgery statistics were determined by review of electronic surgical records. The clinical and microbiologic records were reviewed of all patients with clinically diagnosed endophthalmitis within 6 weeks after cataract surgery at a single university-affiliated hospital between January 2000 and November 2004. main outcome measures: Operative technique, intraoperative complications, and visual acuity. The incidence of acute-onset endophthalmitis after cataract surgery was 0.04% (7/15,920) for cataract surgeries of all methods, 0.05% (6/11,462) for cataract surgery by clear cornea phacoemulsification, and 0.02% (1/4,458) for cataract surgery by methods other than clear cornea phacoemulsification (P = .681, Fisher's exact test). Six of seven (86%) cases occurred in the right eye, and all cases were performed by right-handed surgeons through temporal incisions. Five of seven (71%) patients had relative immune compromise. Four of seven (57%) patients had an intraoperative complication: vitreous loss in three patients and iris prolapse in one patient. Two patients had topical placement of lidocaine 2% gel before povidone-iodine preparation. The visual acuity at final follow up was 20/25 or better in four patients and count fingers or worse in three patients. The incidence of acute-onset endophthalmitis after temporal clear cornea incision phacoemulsification is low (0.05%). Potential risk factors for endophthalmitis may include intraoperative complications, relative immune compromise, application of lidocaine 2% gel before povidone-iodine preparation, and inferior incision location.
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                Author and article information

                Journal
                Curr Opin Ophthalmol
                Curr Opin Ophthalmol
                COOPH
                Current Opinion in Ophthalmology
                Lippincott Williams & Wilkins
                1040-8738
                1531-7021
                January 2017
                07 December 2016
                : 28
                : 1
                : 73-80
                Affiliations
                [a ]Cataract and Primary Eye Care Service, Wills Eye Hospital, Philadelphia, Pennsylvania
                [b ]SurgiCenter of Vineland, Vineland, New Jersey
                [c ]Department of Research, Wills Eye Hospital
                [d ]Division of Biostatistics, Thomas Jefferson University
                [e ]Ophthalmology, Wills Eye Hospital
                [f ]Wills Eye Hospital, Philadelphia, Pennsylvania, USA
                Author notes
                Correspondence to Sydney L. Tyson, MD, MPH, Wills Eye Hospital, 840 Walnut Street, Suite 1230, Philadelphia, PA 19107, USA. Tel: +1 856 691 8188; e-mail: sydtyson@ 123456comcast.net
                Article
                280106 00014
                10.1097/ICU.0000000000000329
                5145248
                27653606
                763703b3-fcef-4f43-a165-908710116d9a
                Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

                History
                Categories
                CATARACT SURGERY AND LENS IMPLANTATION: Edited by Natalie A. Afshari
                Custom metadata
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                cataract postoperative care,cystoid macular edema,intravitreal injection,moxifloxacin hydrochloride,transzonular injection,triamcinolone acetonide

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