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      Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system

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          Abstract

          Purpose

          To compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert ®), system S (Hoya iSert ® 250/251), system T (Tecnis ® iTec), and a manual system (Monarch ® III Delivery System).

          Setting

          Six study sites (four in Spain and two in France).

          Design

          Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study.

          Materials and methods

          Subjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit.

          Results

          One hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]).

          Conclusion

          Preloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system.

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          Most cited references29

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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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            Induced astigmatism with 2.2- and 3.0-mm coaxial phacoemulsification incisions.

            To evaluate the difference between 2.2-mm incision micro-coaxial phacoemulsification and traditional 3.0-mm coaxial phacoemulsification with respect to surgically induced astigmatism after temporally oriented clear corneal incision cataract surgery. This prospective, randomized, intra-patient controlled study comprised 22 patients who underwent clear corneal cataract surgery in both eyes. One eye received 2.2-mm incision micro-coaxial phacoemulsification with intraocular lens (IOL) implantation and the fellow eye received traditional 3.0-mm coaxial incision phacoemulsification with IOL implantation. The 2.2-mm incisions were created with a diamond keratome after a 200-microm groove was constructed in clear cornea at the temporal limbus. The 3.0-mm incisions were created without a pre-cut groove, using a metal keratome. All cases were uncomplicated. Pre- and postoperative keratometric astigmatism at 6 weeks was measured using a hand held Nikon Retinomax K-plus 2 Autorefractor. Three methods were used to analyze the surgically induced astigmatism (SIA) data: 1) algebraic analysis of the magnitude of keratometric astigmatism induced by the surgery, 2) magnitude of SIA by vector analysis, and 3) aggregate analysis of astigmatism using vector analysis. The mean change in the magnitude of keratometric astigmatism was 0.10+/-0.08 diopters (D) with the 2.2-mm micro-coaxial incisions and 0.32+/-0.20 D with the 3.0-mm traditional incisions (P=.0002). Usingvector analysis, the mean magnitude of SIA was 0.35+/-0.21 D with the 2.2-mm incisions and 0.67+/-0.48 D (P=.006) with the 3.0-mm incisions. Surgically induced astigmatism with 2.2-mm micro-coaxial incisions and traditional 3.0-mm clear corneal incisions with intra-patient control resulted in statistically and clinically significant reduction in surgically induced astigmatism with the smaller incision size.
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              • Article: not found

              Postoperative corneal shape changes: microincision versus small-incision coaxial cataract surgery.

              To compare changes in corneal topography and in regular and irregular astigmatism after coaxial clear corneal microincision cataract surgery (MICS) and after coaxial small-incision cataract surgery (SICS).
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2018
                21 August 2018
                : 12
                : 1495-1503
                Affiliations
                [1 ]Department of Ophthalmology, Hospital Universitario Donostia, San Sebastián, Spain, mendicutejavier@ 123456gmail.com
                [2 ]Department of Ophthalmology, Ophthalmic Institute, North of France, Somain, France
                [3 ]Ophthalmology Unit, Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA
                [4 ]Medical Affairs, Alcon Laboratories, Inc., Fort Worth, TX, USA
                Author notes
                Correspondence: Javier Mendicute, Department of Ophthalmology, Hospital Universitario Donostia, Paseo Dr Beguiristáin, 115, 20014 San Sebastián, Spain, Tel +34 94 332 2233, Email mendicutejavier@ 123456gmail.com
                Article
                opth-12-1495
                10.2147/OPTH.S166776
                6109656
                30174410
                f38919ce-0e17-4d37-9281-1d8ae801f0f6
                © 2018 Mendicute 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 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.

                History
                Categories
                Clinical Trial Report

                Ophthalmology & Optometry
                corneal incision,intraocular lens,preloaded iol injector,ultrasert
                Ophthalmology & Optometry
                corneal incision, intraocular lens, preloaded iol injector, ultrasert

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