Two-Year Clinical Outcomes of the PAUL Glaucoma Implant in White Patients With Refractory Glaucoma.

Abstract

Prcis: This prospectively collected case series of 56 eyes having PAUL glaucoma implant (PGI) surgery is the first to demonstrate its medium-term safety and effectiveness in what is essentially an exclusively Caucasian population.

Background: To report 2-year outcomes from a single-center cohort undergoing PGI surgery.

Methods: Prospectively collected data on patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021.

Results: Of 53 patients, 56 eyes were included. Complete and qualified success rates (95% CI) were 52% (37-66) and 89% (80-96) for criterion A ( intraocular pressure [IOP]≤21 mm Hg), 48% (36-61) and 79% (67-88) for criterion B (IOP≤18 mm Hg), 45% (32-57) and 64% (52-77%) for criterion C (IOP≤15 mm Hg) and 27% (16-40) and 38% (25-50) for criterion D (IOP≤12 mm Hg), respectively. Mean IOP decreased from 25.43 mm Hg (7-48 mm Hg) to 11.25 mm Hg (3-24 mm Hg) (reduction of 50%) after 24 months with a reduction of IOP-lowering agents from 3.50 (1-5) to 0.46 (0-3). One eye needed an injection of viscoelastic due to significant hypotony with AC shallowing; 3 eyes received a Descemet membrane endothelial keratoplasty because of persistent corneal decompensation; 9 eyes developed tube exposure which required conjunctival revision with additional pericardial patch graft, with 5 of these eyes eventually needing tube explantation. An intraluminal prolene stent was removed in 24 eyes (42.9%) after a mean time period of 5.67 months (2-15 m). Mean IOP before removal was 21.4 mm Hg (12-40 mm Hg) and decreased to 11.15 mm Hg (6-20 mm Hg).

Conclusions: PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. The use of an intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further noninvasive IOP lowering during the postoperative course.