Phaco-Trabeculectomy Versus Phaco-XEN63 Gel Stent in Primary Open-Angle Glaucoma and Cataract: A Retrospective Comparative Study.

Purpose

To compare outcomes of XEN® Gel Stent implantation (Phaco-XEN63) versus trabeculectomy (Phaco-Trab) combined with phacoemulsification in patients with primary open-angle glaucoma and visually significant cataract.

Methods

Retrospective, single-center study. Surgical success at 12 months was defined with three intraocular pressure (IOP) thresholds: ≤18 mmHg with ≥20% reduction (criterion A), ≤15 mmHg (criterion B), and ≤12 mmHg (criterion C). Outcomes were classified as complete success (without medications) and qualified success (with or without medications). IOP, best-corrected visual acuity (BCVA), number of antiglaucoma medications, postoperative procedures and complications were recorded through 12 months.

Results

Thirty-four eyes were included (Phaco-Trab, n = 16; Phaco-XEN63, n = 18). Both procedures significantly reduced IOP and medication use versus baseline. From 1 to 12 months, mean IOP was consistently lower after Phaco-Trab (all p < 0.05); at 12 months, mean IOP was 9.73 ± 3.68 mmHg (Phaco-Trab) and 13.41 ± 3.00 mmHg (Phaco-XEN63). Medication reduction was greater with Phaco-Trab (p = 0.017). Complete success was more frequent after Phaco-Trab under all three criteria, whereas qualified success differed significantly only under criterion C. Postoperative interventions were more frequent after Phaco-XEN63. Difference in BCVA change was not statistically significant.

Conclusions

Both combined procedures effectively lowered IOP and reduced medication burden. However, Phaco-Trab was associated with lower IOP at 12 months and higher complete success rates. Given the small sample size and the retrospective, non-randomized design, these findings should be interpreted cautiously, particularly regarding qualified success and comparative safety.