Lenzhofer, Markus, Hohensinn, Melchior, Steiner, Veit, Hitzl, Wolfgang, Runge, Christian, Trost, Andrea, Colvin, Hans Peter, Brunner, Susanne, Preishuber‐Pflügl, Julia, and Reitsamer, Herbert A.
Purpose: To investigate the surgical success and efficacy of XEN45 implantation (XEN45 μm, AbbVie Inc., USA) with and without combined cataract surgery up to the first 5 years. Methods: In a prospective observational monocentric trial, 192 eyes of 157 patients with open‐angle glaucoma received either XEN45 implants only (solo surgery group) or combined surgery/cataract surgeries (combined surgery group). Surgical success (qualified and full success; IOP‐limit: ≤12, 15, 18, 21 mmHg), time to secondary IOP‐lowering procedure, IOP and number of IOP‐lowering medications were analysed for 1, 2, 3, 4 and 5 years. Results: Compared to baseline, IOP (24.1 ± 8.1 to 12.6 ± 2.8 mmHg, −48%, p < 0.001) and the number of IOP‐lowering medications (3.0 ± 1.0 to 1.5 ± 1.2, −50%, p < 0.001) decreased significantly at 5 years. Although no differences between IOP and the number of IOP‐lowering medication courses between the groups were detected at 5 years (p > 0.11), the combined procedure (63%, 37%) showed better success rates compared to the solo procedure (36%, 13%) in the definition IOP ≤18 and ≤12 mmHg (p = 0.035, 0.028). Solo XEN45 procedures had a higher rate of secondary IOP‐lowering procedures compared to combined XEN45 cataract procedures (hazard ratio: 2.02, 95%CI: 1.03–3.97, p = 0.04). Twenty per cent of the eyes, including both procedures, required a secondary IOP‐lowering procedure within 5 years. Conclusions: The XEN45 implant is effective in lowering IOP and the number of IOP‐lowering medications in patients with open‐angle glaucoma in the mid‐term. Comparing XEN45 implant results with the results of trabeculectomy available in current literature, we speculate that there might be a higher surgical success rate without medications in favour of trabeculectomy. [ABSTRACT FROM AUTHOR]