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      Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

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          Abstract

          Purpose. To report the long-term follow-up results in patients with cataract and primary open-angle glaucoma (POAG) randomly assigned to cataract surgery combined with micro-bypass stent implantation or phacoemulsification alone. Methods. 36 subjects with cataract and POAG were randomized in a 1 : 2 ratio to either iStent implantation and cataract surgery (combined group) or cataract surgery alone (control group). 24 subjects agreed to be evaluated again 48 months after surgery. Patients returned one month later for unmedicated washout assessment. Results. At the long-term follow-up visit we reported a mean IOP of 15,9 ± 2,3 mmHg in the iStent group and 17 ± 2,5 mmHg in the control group ( p = NS). After washout, a 14,2% between group difference in favour of the combined group was statistically significant ( p = 0,02) for mean IOP reduction. A significant reduction in the mean number of medications was observed in both groups compared to baseline values ( p = 0,005 in the combined group and p = 0,01 in the control group). Conclusion. Patients in the combined group maintained low IOP levels after long-term follow-up. Cataract surgery alone showed a loss of efficacy in controlling IOP over time. Both treatments reduced the number of ocular hypotensive medications prescribed. This trial is registered with: NCT00847158.

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          Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.

          To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Prospective, randomized, open-label, controlled, multicenter clinical trial. A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only. The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P<0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved ≥20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Adverse effects of topical antiglaucoma medication. II. The outcome of filtration surgery.

            To determine the effect of long-term topical antiglaucoma therapy on the results of glaucoma filtration surgery and to relate any differences to the cell population profile of the conjunctiva. Filtration surgery was performed in 124 patients (trabeculectomy in 112 and triple procedures [trabeculectomy, cataract extraction, and intraocular lens implantation] in 12), and the outcome of these procedures was assessed after a minimum follow-up of 6 months. A conjunctival biopsy specimen was obtained at the time of surgery. The patients were divided into four groups according to the type of topical therapy administered. The duration of therapy tended to be greater for the patients treated with a greater number of medication types. The outcome of trabeculectomy was assessed in 106 of the patients. In comparison with the briefly treated-primary surgery group, the success rate of trabeculectomy (90% [n = 28]) was similar to that in the group treated with beta-blockers (93% [n = 29]). The trabeculectomy success rate for patients treated with beta-blockers and miotics was significantly lower (72%, P < .01 [n = 29]), and that for the group treated with beta-blockers, miotics, and sympathomimetics was even lower (45%, P < .001, [n = 20]). Various treatment regimens were associated with differential effects on the success rate of trabeculectomy. Long-term topical combination therapy was identified as a significant risk factor for failure of trabeculectomy. Preoperative conjunctival cell counts from patients whose trabeculectomies were successful were compared with those whose trabeculectomies failed. Failure was associated with significantly more pale cells (P < .01), macrophages (P < .05), and lymphocytes (P < .05) in the epithelium; fibroblasts (P < .05) and macrophages (P < .05) in the superficial substantia propria; and both macrophages and lymphocytes in the deep substantia propria (P < .01). Thus, preoperative subclinical conjunctival inflammation induced by previous topical medication was identified as a risk factor for failure of trabeculectomy.
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              Intraocular pressure reduction after phacoemulsification with intraocular lens implantation in glaucomatous and nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and open-angle glaucoma.

              To study the long-term effects of phacoemulsification with intraocular lens (IOL) implantation in nonglaucomatous and glaucomatous eyes. Phillips Eye Institute, Minneapolis, Minnesota, and private practice, Savannah, Georgia, USA. Intraocular pressure (IOP) after phacoemulsification with IOL implantation was retrospectively reviewed. Eyes were divided into 5 groups by preoperative IOP. Data were recorded preoperatively, 1 year postoperatively, and at the final check. Analysis included preoperative IOP versus IOP at 1 year and final IOP, percentage of eyes with elevated or reduced IOP postoperatively, patient age at surgery, and years of postoperative follow-up. The study comprised 124 eyes. The final mean IOP reduction was 8.5 mm Hg (34%) in the 29 to 23 mm Hg group, 4.6 mm Hg (22%) in the 22 to 20 mm Hg group, 3.4 mm Hg (18%) in the 19 to 18 mm Hg group, and 1.1 mm Hg (10%) in the 17 to 15 mm Hg group. In the 14 to 5 mm Hg group, IOP increased by 1.7 mm Hg (15%). Intraocular pressure reduction was proportional to preoperative IOP; the highest preoperative IOPs decreased the most and the lowest increased slightly. One-year IOP reductions were sustained for 10 years and were similar in patients of all ages. The IOP reductions were similar to previously reported reductions in nonglaucomatous eyes, indicating that the aging crystalline lens may be a major cause of ocular hypertension and glaucoma and that phacoemulsification with IOL implantation may help prevent and treat adult glaucoma.
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                Author and article information

                Journal
                J Ophthalmol
                J Ophthalmol
                JOPH
                Journal of Ophthalmology
                Hindawi Publishing Corporation
                2090-004X
                2090-0058
                2015
                26 October 2015
                : 2015
                : 795357
                Affiliations
                Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy
                Author notes

                Academic Editor: Colin Clement

                Article
                10.1155/2015/795357
                4637500
                26587282
                48bcaf8a-01fd-4838-a719-7603f44d7503
                Copyright © 2015 Antonio Maria Fea et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 2 September 2015
                : 7 October 2015
                Categories
                Clinical Study

                Ophthalmology & Optometry
                Ophthalmology & Optometry

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