Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
Clinical outcomes of the PAUL Glaucoma implant for neovascular glaucoma.
СтатьяНазвание и аннотация: Перевод в очереди
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Deubel Carolin, Walz Wolfgang, Petrak Michael, Holz Frank G, Liegl Raffael, Mercieca Karl, Liegl Née Weber Constance
Аннотация
PURPOSE: In neovascular glaucoma (NVG), surgical interventions such as glaucoma drainage devices (GDD), may become necessary, especially when other therapies prove ineffective. The PAUL® Glaucoma Implant (PGI), with its refined, smaller drainage tube, presents a promising solution for lowering intraocular pressure (IOP) in such complex cases. This study aims to evaluate the PGI's effectiveness and safety in managing IOP in patients with NVG.
METHODS: This study reviewed medical records of patients who underwent PGI surgery for NVG at the University Hospital Bonn between May 2021 and January 2024. Preoperative and follow-up data, including IOP, BCVA, visual field progression, and complications, were collected prospectively. Success was defined using four IOP-based criteria (≤ 21, ≤ 18, ≤ 15, and ≤ 12 mmHg) per World Glaucoma Association (WGA) guidelines (World Glaucoma Association et al. 2009). Outcomes were classified as complete (without medication) or qualified (with or without medication). Failure included hypotony-related complications, need for further surgery, or PGI explantation. The primary endpoint was success rate by IOP criteria; secondary endpoints included changes in IOP, BCVA, medication use, complications, and impact of Prolene stent removal.
RESULTS: The study analyzed 23 eyes from 22 patients undergoing PGI surgery, with the majority being male (60.9%) and Caucasian (95.7%), and with an average age of 65.2 years. Success rates were highest for IOP ≤ 21 mmHg (60%-80% at 12 months) and declined with stricter thresholds, with only 10% maintaining IOP ≤ 12 mmHg. Prior to surgery, the mean intraocular pressure (IOP) was 27.22 mmHg. Following the procedure, a substantial reduction was observed, with IOP decreasing to 12.95 mmHg at the 12-month follow-up-representing an average decrease of 53.1%.
CONCLUSION: The PGI demonstrates significant IOP reduction in NVG, with sustained success at higher IOP thresholds. However, maintaining very low IOP levels remains challenging.
METHODS: This study reviewed medical records of patients who underwent PGI surgery for NVG at the University Hospital Bonn between May 2021 and January 2024. Preoperative and follow-up data, including IOP, BCVA, visual field progression, and complications, were collected prospectively. Success was defined using four IOP-based criteria (≤ 21, ≤ 18, ≤ 15, and ≤ 12 mmHg) per World Glaucoma Association (WGA) guidelines (World Glaucoma Association et al. 2009). Outcomes were classified as complete (without medication) or qualified (with or without medication). Failure included hypotony-related complications, need for further surgery, or PGI explantation. The primary endpoint was success rate by IOP criteria; secondary endpoints included changes in IOP, BCVA, medication use, complications, and impact of Prolene stent removal.
RESULTS: The study analyzed 23 eyes from 22 patients undergoing PGI surgery, with the majority being male (60.9%) and Caucasian (95.7%), and with an average age of 65.2 years. Success rates were highest for IOP ≤ 21 mmHg (60%-80% at 12 months) and declined with stricter thresholds, with only 10% maintaining IOP ≤ 12 mmHg. Prior to surgery, the mean intraocular pressure (IOP) was 27.22 mmHg. Following the procedure, a substantial reduction was observed, with IOP decreasing to 12.95 mmHg at the 12-month follow-up-representing an average decrease of 53.1%.
CONCLUSION: The PGI demonstrates significant IOP reduction in NVG, with sustained success at higher IOP thresholds. However, maintaining very low IOP levels remains challenging.