Two‐year outcomes of primary PAUL glaucoma implant using tube ligature technique without intraluminal stent

PURPOSE: To evaluate 2-year outcomes and complications following primary PAUL Glaucoma Implant (PGI) surgery using an external tube ligation technique without intraluminal stenting or antimetabolites. METHODS: This prospective study included 85 eyes of 85 consecutive patients with medically uncontrolled glaucoma undergoing primary glaucoma surgery. Fixed 24-month outcomes were available for 80 eyes. All procedures were performed by a single surgeon using external tube ligation with two 6-0 polyglactin sutures. Success was defined as IOP between 6 and 21 mmHg with ≥20% reduction from medicated baseline, categorised as complete (no medications) or qualified (with medications). Preoperative and postoperative outcomes were compared using paired analyses. Kaplan-Meier analysis estimated cumulative success, and logistic regression evaluated factors associated with choroidal effusion. RESULTS: Mean IOP decreased from 33 ± 8 to 12 ± 4 mmHg at 24 months (p < 0.001), corresponding to a 62% reduction. Medications decreased from 4.1 ± 0.9 to 1.0 ± 1.2 (p < 0.001). At 24 months, complete and qualified success rates were 43% and 84%, respectively. Choroidal effusion occurred in 25 eyes (29%) and three required surgical drainage. More preoperative medications were associated with choroidal effusion after adjustment for treated preoperative IOP (OR 1.87, 95% CI: 1.03-3.39, p = 0.040). No endophthalmitis occurred. Exfoliation glaucoma showed higher complete success than other glaucoma types (54% vs. 31%, p = 0.045). CONCLUSIONS: Primary PGI implantation using external ligation achieved substantial two-year IOP and medication reduction. Early choroidal effusion was relatively common but usually self-limiting.