Clinical outcomes of the PAUL® Glaucoma implant for refractory glaucoma: three-year results.

PURPOSE: To report three-year outcomes undergoing PAUL® Glaucoma Implant (PGI) surgery in a single-centre cohort.

METHODS

A retrospective cohort study including patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April to September 2021. Patients were enrolled in a database at the time of surgery, with follow-up data collected at each visit. The primary outcome was the success rate based on predefined IOP criteria (A ≤ 21, B ≤ 18, C ≤ 15, and D ≤ 12 mmHg). Secondary outcomes included IOP, BCVA, IOP-lowering medications, complications, and intraluminal Prolene stent removal.

RESULTS

Sixty eyes of 56 patients were included. Qualified and complete success rates (95% CI) were 88% (80-97) and 43% (30-56) for Criterion A, 67% (53-78) and 37% (23-50) for Criterion B, 43% (30-57) and 27% (15-39%) for Criterion C and 30% (18-42) and 22% (12-33) for Criterion D. Mean IOP decreased from 26.73 mmHg (7-48) to 10.83 mmHg (4-20) (reduction of 54%) over 36 months with a reduction in IOP-lowering agents from 3.38 to 0.57. Three eyes developed hypotony requiring intervention, one required DMEK for corneal decompensation, and seven required conjunctival revision for tube exposure. The Prolene stent was removed in 29 eyes (49.2%) after a mean of 4.44 months, reducing IOP from 23.58 to 12.04 mmHg.

CONCLUSIONS

PGI surgery effectively reduces IOP and medication burden in refractory glaucoma, with sustained efficacy over three years. The intraluminal Prolene stent enables further non-invasive IOP reduction postoperatively.