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

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, I2 = 96.10%, p < 0.001) and 2.34 (k = 12, n = 482, 95% CI: 1.99-2.69, I2 = 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%, I2 = 80.30%) and 92.40% (k = 11, n = 490, 95% CI: 88.83%-95.40%, I2 = 41.40%), respectively. Postoperative complications such as hypotony (k = 13, n = 39, 6.05%, 95% CI: 2.81%-10.16%, I2 = 57.70%) and hyphema (k = 13, n = 33, 5.63%, 95% CI: 2.52%-9.61%, I2 = 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, I2 = 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.