Clinical Efficacy and Safety of the PAUL Glaucoma Implant: A Systematic Review and Meta‐Analysis

ABSTRACT Background The PAUL glaucoma implant (PGI) is a novel valveless glaucoma drainage device featuring a large endplate surface area to enhance aqueous absorption, as well as a smaller internal and external tube diameter to minimise postoperative hypotony and corneal endothelial damage, particularly in eyes with refractory glaucoma. This is the first meta‐analysis on the clinical efficacy and safety of the PGI. Methods Medline, Embase and CENTRAL databases were searched for articles on the use of the PGI. A meta‐analysis of single means and binary outcomes was conducted to assess clinical endpoints. Results A total of 15 studies with 640 eyes were analysed. At the 12 months postoperatively, the mean reduction in IOP and IOP‐lowering medications from baseline were 16.11 mmHg ( k = 13, n = 550, 95% CI: 12.91–19.31 mmHg, I 2 = 96.10%, p < 0.001) and 2.34 ( k = 12, n = 482, 95% CI: 1.99–2.69, I 2 = 91.90%, p < 0.001), respectively. The mean complete and qualified success rates at 12 months postoperatively were 50.22% ( k = 8, n = 209, 95% CI: 38.73%–61.70%, I 2 = 80.30%) and 92.40% ( k = 11, n = 490, 95% CI: 88.83%–95.40%, I 2 = 41.40%), respectively. Postoperative complications such as hypotony ( k = 13, n = 39, 6.05%, 95% CI: 2.81%–10.16%, I 2 = 57.70%) and hyphema ( k = 13, n = 33, 5.63%, 95% CI: 2.52%–9.61%, I 2 = 56.60%) were uncommon, and sight‐threatening complications such as corneal decompensation and endophthalmitis were rare. There was no statistically significant difference in mean visual acuity compared to baseline ( k = 7, n = 312, MD: −0.03 logMAR, 95% CI: −0.09–0.04 logMAR, I 2 = 0.00%, p = 0.43). Conclusions This meta‐analysis provides quantitative evidence supporting the clinical efficacy and safety of the PGI in patients with refractory glaucoma.