Tube Versus Trabeculectomy IRIS Registry Study: 1-Year Secondary Treatment Outcomes

American journal of ophthalmology(2023)

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摘要
center dot PURPOSE: To describe 1-year secondary outcomes in the Tube Versus Trabeculectomy IRIS (R) (Intelligent Reg-istry In Sight) Registry Study (TVTIRIS ), and to compare to the TVT randomized controlled trial (TVTRCT).center dot DESIGN: TVTIRIS was a retrospective cohort study.center dot METHODS: The 2013-2017 IRIS Registry was used to identify eyes that received a tube shunt (tube) or trabeculectomy after a previous trabeculectomy and/or cataract surgery and had 1 year of follow-up. The TVTRCT compared a Baerveldt 350-mm2 glaucoma im-plant to trabeculectomy in similar eyes. center dot RESULTS: In the TVTIRIS cohort, the tube (n = 236, 56.3%) and trabeculectomy (n = 183, 43.7%) groups had similar and significant reductions in intraocular pres-sure (IOP) from baseline to 1 year. In the tube group, IOP (mean +/- SD) decreased from 26.6 +/- 6.5 mm Hg at baseline to 14.3 +/- 4.8 mm Hg at 1 year. In the tra-beculectomy group, IOP decreased from 25.3 +/- 6.4 mm Hg at baseline to 13.5 +/- 5.2 mm Hg at 1 year. The tra-beculectomy groups from both studies had similar 1-year IOP reduction ( P = .18), although the TVTRCT cohort used fewer medications at all time points ( P < .01). There were more pronounced differences in the mean IOP and medications between the tube groups in the 2 studies, pre-sumably due to the inclusion of valved tubes in TVTIRIS. More reoperations occurred in TVTIRIS.center dot CONCLUSIONS: The TVTIRIS tube and trabeculectomy groups had comparable 1-year IOP reduction, although trabeculectomy eyes used fewer glaucoma medications. The trabeculectomy group in TVTIRIS and TVTRCT had similar IOP and medication reduction at 1 year. Randomized controlled trials and electronic health record data both provide invaluable insight into surgical outcomes. (Am J Ophthalmol 2023;256: 97-107. (c) 2023 Elsevier Inc. All rights reserved.)
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关键词
Glaucoma,Real-world evidence,Tube, Trabeculectomy,electronic health records,glaucoma drainage device,randomized controlled trials
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