Early safety and efficacy outcomes of the PAUL glaucoma implant in a Spanish population: A retrospective study.

Abstract

Purpose: The purpose of the study was to evaluate the efficacy and safety of the PAUL glaucoma implant (PGI) in refractory glaucoma patients, during the early postoperative period.

Methods: We conducted a retrospective, cohort study of patients that had received a PGI between February 2022 and December 2023. An intraluminal polypropylene suture was placed to prevent early hypotony in all cases. Demographics, intraocular pressure (IOP), and medication variation were evaluated for up to 6 months. The success rate was stratified into <18 mmHg and 30% from baseline or <15 mmHg and 40% IOP reduction. The safety outcomes were also analyzed.

Results: Sixteen eyes from 16 patients were included in the analysis. Fifteen of them had had a previous surgical glaucoma procedure. At 6 months, IOP decreased from 26.6 (±6.2) to 15.3 (±4.6) mmHg, with fewer glaucoma medications, from a median (interquartile range) of 3 (2-3) - 1.5 (0-2) (P < 0.005). Twelve (75%) and seven (43.8%) eyes met the qualified and complete success definition for the first category, and eight (50%) and four (25%) met the second criterion. One case with self-limiting choroidal detachments, but >6 mmHg IOP was found in our cohort.

Conclusion: The PGI seems to be safe and effective from the early postoperative period. The IOP reduction rate could make it suitable for patients with refractory moderate-to-advanced glaucoma.