Efficacy And Safety Of The Paul Glaucoma Implant: A Systematic Review And Meta-Analysis

To investigate the efficacy and safety of the PAUL Glaucoma Implant (PGI) in eyes with glaucoma. We synthesized evidence from available studies to assess PGI outcomes across various glaucoma subtypes.

A systematic review and meta-analysis.

We systematically searched Pubmed, Cochrane, Embase, Scopus, Web of Science, Google Scholar, and Medline for studies assessing efficacy and safety outcomes in eyes with PGI. Data analysis utilized a random-effects model in R software. Heterogeneity was examined with the Cochran Q test and I² statistics; p values inferior to 0.10 and I² >25% were considered significant for heterogeneity.

Sixteen observational studies, including 663 eyes from 623 patients undergoing PGI, were analyzed. A significant reduction in intraocular pressure (IOP) was observed on day 1 (MD: -16.43 mmHg; 95% CI: -19.75 to -13.10; p < 0.0001; I² = 83.4%). Mean IOP at 1 and 12 months was 15.26 mmHg (95% CI: 14.13–16.39; I² = 79.4%) and 13.72 mmHg (95% CI: 13.06–14.38; I² = 73.6%), respectively. The mean number of glaucoma medications at 1 and 12 months was 0.72 (95% CI: 0.43–1.00; I² = 82.3%) and 0.80 (95% CI: 0.53–1.08; I² = 93.1%), respectively. PGI demonstrated complete and qualified success rates of 60.84% and 76.59%. Complications included hypotony (7.00%), hyphema (6.65%), and tube exposure (5.14%).

Our meta-analysis suggests that PGI effectively reduces intraocular pressure in various glaucoma subtypes and decreases the need for glaucoma medications with an acceptable safety profile. Further long-term studies are required to confirm its efficacy and safety.