Tube Versus Trabeculectomy IRIS® Registry One-Year Composite Outcome Analysis with Comparisons to the Randomized Controlled Trial: (60 characters or fewer): Tube vs Trab IRIS Registry 1-Year Composite Outcome Analysis.
Compare one-year results for the composite treatment outcome from the Tube Versus Trabeculectomy (TVT) Randomized Controlled Trial (RCT) to those from an Intelligent Research In Sight (IRIS®) Registry cohort of analogous eyes.Retrospective clinical study with comparison to an RCT.Subjects: Eyes in the IRIS Registry receiving either a glaucoma drainage implant (tube) or trabeculectomy after a previous trabeculectomy and/or cataract extraction with data for one-year follow-up analyses.Eyes were classified as failing if, they had hypotony (intraocular pressure (IOP)≤5 mmHg) or inadequate IOP control (IOP>21 mmHg or not reduced at least 20% below baseline) on two consecutive follow-up visits after three months, a reoperation for glaucoma, or no light perception vision; and as successful otherwise. Failure risk was compared by treatment, demographic, and clinical variables, and compared to analogous failure risks from the TVT RCT.The TVT IRIS Registry cohort included 419 eyes, 236 tube eyes (56.3%) and 183 trabeculectomy eyes (43.7%). In this cohort, there was no significant failure risk difference (12.3% for tube eyes and 16.4% for trabeculectomy eyes, P=0.231). Comparting the studies, there was a significantly greater risk of failure in the TVT IRIS Registry tube eyes than in the TVT RCT tube eyes (3.8%; P<0.001). Failure reasons included reoperations for glaucoma (none in the TVT RCT at one-year).Our results were different from the TVT RCT. Possible reasons include non-Baerveldt tubes, greater severity among tube eyes, and practice patterns that reflect real-world data, which are different than RCTs.
Authors: Elizabeth A Vanner, Catherine Q Sun, Matthew J McSoley, Patrice J Persad, William J Feuer, Flora Lum, Scott P Kelly, Richard K Parrish, Ta C Chang, Steven J Gedde