Outcomes of the Paul Glaucoma Implant in an Ambispective Multicenter Study: 12-Month Follow-Up

Objective: The aim of this study was to evaluate the safety and efficacy of the Paul Glaucoma Implant (PGI) in a multicenter Argentine cohort with 12 months of follow-up. Methods: This ambispective multicenter study included patients who underwent PGI implantation between November 2022 and July 2024 by glaucoma specialists across Argentina, with a minimum follow-up of 12 months. Primary outcomes were intraocular pressure (IOP) reduction and success rates, defined as complete success (≥20% IOP reduction with IOP ≥6 and ≤21 mmHg without medications), qualified success (same criteria with ≥1 medication), and failure based on predefined efficacy and safety criteria, including additional glaucoma surgery, device removal, or clinically significant hypotony. Secondary outcomes included changes in medication use, best-corrected visual acuity (BCVA), and postoperative complications. Results: Sixty-six eyes were included in the overall analysis. Mean IOP decreased from 31.2 ± 9.1 mmHg preoperatively to 12.8 ± 4.7 mmHg at 12 months (p < 0.01). Medications were reduced from 3.5 ± 0.8 to 1.3 ± 1.2 (p < 0.01). Among the 65 eyes with evaluable 12-month follow-up, 50 eyes (76.9%) achieved complete success, 14 (21.5%) qualified success, and 1 (1.5%) failure. Complications were ocular hypertension (25%), tube or plate exposure (10%), choroidal detachment (7%), and hypotony (5%). BCVA remained stable in 28 eyes (43.8%), improved in 15 (23.4%), and worsened in 21 (32.8%). Conclusions: The PGI achieved significant and sustained IOP reduction with marked medication decrease at 12 months. Most complications were mild or moderate. These findings support the PGI as an effective and safe non-valved implant for refractory glaucoma in Latin American populations.