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      Systematische Übersicht über die Methoden und Qualität der Meldung von Komplikationen in Studien zur Beurteilung von innovativen glaukomchirurgischen Verfahren

      other
      a , * , b
      Kompass Ophthalmologie
      S. Karger AG
      Chirurgie, Unerwünschte, Wirkungen

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          Zusammenfassung

          Das Ziel dieser systematischen Übersichtsarbeit ist die Ermittlung der Art der Meldung von Komplikationen bei der mikroinvasiven Glaukomchirurgie (MIGS) in randomisierten kontrollierten Studien (RCTs) und die Bestimmung der Qualität dieser Meldungen im Vergleich zur CONSORT-Erweiterung für Schäden. Aus einer Datenbank mit systematischen Übersichtsarbeiten und der aktuellen Literatur wurden MIGS-Verfahren bewertende RCTs ermittelt. Die Studien wurden im Vergleich zur CONSORT-Erweiterung für Schäden bewertet, um die Qualität der Berichterstattung über Schäden zu quantifizieren. Für die CONSORT-Checkliste wurden einfache deskriptive Statistiken berechnet. 21 Studien wurden als geeignet zur Einbeziehung ermittelt, davon untersuchten 14 Studien iStent, 1 Trabectome, 3 Hydrus, 1 Cypass, 1 PreserFlo MicroShunt und 1 Studie die Excimer-Laser-Trabekulotomie. Die durchschnittliche Anzahl der von den Studien erfüllten Punkte der CONSORT-Checkliste für Schäden betrug 10 von 16. Keine der Studien verwendete ein validiertes Instrument, um die Schwere der Schäden zu melden, und nur 4 hatten eine Liste oder Definition der unerwünschten Ereignisse. Eine Analyse der Schäden wurde in 19 von 21 Studien (90%) durchgeführt. In 19 von 21 Studien wurden geeignete Metriken für die Meldung von Raten unerwünschter Ereignisse verwendet, aber in nur 4 Studien wurde versucht, diesen unerwünschten Ereignissen einen Schweregrad zuzuordnen. Zusammenfassend lässt sich sagen, dass die meisten der die MIGS-Verfahren bewertenden Studien sich bemühen, Daten zu Schäden anzuerkennen, dies jedoch nicht einheitlich gut oder auf die gleiche Weise geschieht. Ein validiertes Instrument zur Meldung des Schweregrads und eine Standardliste der Komplikationen für die MIGS würden entscheidend zur Lösung dieses Problems beitragen.

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          Most cited references30

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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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            Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up.

            To assess the long-term safety and efficacy of a single trabecular micro-bypass stent with concomitant cataract surgery versus cataract surgery alone for mild to moderate open-angle glaucoma. Twenty-nine investigational sites, United States. Prospective randomized controlled multicenter clinical trial. Eyes with mild to moderate glaucoma with an unmedicated intraocular pressure (IOP) of 22 mm Hg or higher and 36 mm Hg or lower were randomly assigned to have cataract surgery with iStent trabecular micro-bypass stent implantation (stent group) or cataract surgery alone (control group). Patients were followed for 24 months postoperatively. The incidence of adverse events was low in both groups through 24 months of follow-up. At 24 months, the proportion of patients with an IOP of 21 mm Hg or lower without ocular hypotensive medications was significantly higher in the stent group than in the control group (P=.036). Overall, the mean IOP was stable between 12 months and 24 months (17.0 mm Hg ± 2.8 [SD] and 17.1 ± 2.9 mm Hg, respectively) in the stent group but increased (17.0 ± 3.1 mm Hg to 17.8 ± 3.3 mm Hg, respectively) in the control group. Ocular hypotensive medication was statistically significantly lower in the stent group at 12 months; it was also lower at 24 months, although the difference was no longer statistically significant. Patients with combined single trabecular micro-bypass stent and cataract surgery had significantly better IOP control on no medication through 24 months than patients having cataract surgery alone. Both groups had a similar favorable long-term safety profile. Dr. Craven was an investigator in the clinical trial of the iStent. Dr. Katz is a consultant to Glaukos and was the medical monitor for the clinical trial of the iStent. Dr. Katz is a stockholder in Glaukos. Mr. Wells and Ms. Giamporcaro are employees of Glaukos. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
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              • Record: found
              • Abstract: found
              • Article: not found

              Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts.

              We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery.
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                Author and article information

                Journal
                KOP
                10.1159/issn.2297-0118
                Kompass Ophthalmologie
                Kompass Ophthalmol
                S. Karger AG
                2297-0118
                2297-0045
                2024
                15 April 2024
                : 10
                : 2
                : 47-51
                Affiliations
                [a ]Belfast Health and Social Care Trust, Belfast, Vereinigtes Königreich
                [b ]Queen’s University Belfast, Belfast, Vereinigtes Königreich
                Author notes
                *Jonathan Bonnar, jbonnar01@qub.ac.uk
                Article
                538411 Kompass Ophthalmol 2024;10:47–51
                10.1159/000538411
                e9c2d7f2-9ec3-40e8-b2f6-9d2adc24aff5
                © 2024 The Author(s). Published by S. Karger GmbH, Freiburg
                History
                Page count
                Figures: 2, Tables: 2, Pages: 5
                Categories
                Übersichtsarbeit

                Medicine
                Chirurgie,Wirkungen,Unerwünschte
                Medicine
                Chirurgie, Wirkungen, Unerwünschte

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