TY - JOUR
T1 - Mid-term surgical success after transscleral ab interno glaucoma gel stent implantation
AU - Lenzhofer, Markus
AU - Hohensinn, Melchior
AU - Steiner, Veit
AU - Hitzl, Wolfgang
AU - Runge, Christian
AU - Trost, Andrea
AU - Colvin, Hans Peter
AU - Brunner, Susanne
AU - Preishuber-Pflügl, Julia
AU - Reitsamer, Herbert A
N1 - Lenzhofer, Hohensinn, Steiner, Hitzl, Colvin, Reitsamer: Department of Ophthalmology and Optometry, Paracelsus Medical University Salzburg, Salzburger Landeskliniken, Salzburg, Austria;
Lenzhofer, Hitzl, Runge, Trost, Brunner, Preishuber- Pflügl, Reitsamer: Research Program Experimental Ophthalmology, Paracelsus Medical University Salzburg, Salzburger Landeskliniken, Salzburg, Austria; Hitzl: Research and Innovation Management (RIM), Team Biostatistics and Publication of Clinical Trial Studies/Machine Learning, Paracelsus Medical University Salzburg, Salzburg, Austria
PY - 2024/9
Y1 - 2024/9
N2 - Purpose: To investigate the surgical success and efficacy of XEN45 implantation (XEN45 mu m, 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.
AB - Purpose: To investigate the surgical success and efficacy of XEN45 implantation (XEN45 mu m, 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.
KW - Efficacy
KW - Mid-term
KW - Migs
KW - Success
KW - XEN45 glaucoma gel microstent
U2 - 10.1111/aos.16668
DO - 10.1111/aos.16668
M3 - Original Article
C2 - 38477813
SN - 1755-375X
VL - 102
SP - e906-e914
JO - ACTA OPHTHALMOLOGICA
JF - ACTA OPHTHALMOLOGICA
IS - 6
ER -