Objectives: To describe a surgical technique and early post-operative outcomes for a novel glaucoma drainage device-the PAUL® glaucoma implant (PGI).
Methods: A consecutive cohort study of subjects who had PGI surgery between February 2019 and May 2020 with a minimum of 6-month follow-up. Primary outcome measures included failure (intraocular pressure (IOP) > 21 mmHg or a <20% reduction of IOP, removal of the implant, further glaucoma intervention or visual loss to no light perception). Secondary outcomes included mean IOP, mean number of medications, logMAR visual acuity (VA) and complications.
Results: Ninety-nine eyes of 97 patients had a preoperative IOP (mean ± standard deviation) of 28.1 ± 9.0 mmHg, falling to 18.2 ± 6.8 mmHg at 1 month, 17.9 ± 6.7 mmHg at 3 months and 13.6 ± 4.7 mmHg at 6 months. 52 patients had a 12-month mean IOP of 13.3 ± 4.4 mmHg. The mean change in number of medications was a reduction of 2.38 ± 1.48. A significant reduction in the number of medications and intraocular pressure was demonstrated after PGI (p < 0.0001). No significant change was demonstrated in VA (p = 0.1158). A total of nine cases were deemed failures (six had <20% IOP reduction from baseline and three had IOP >21 mmHg). Thirty-eight (38.4%) of eyes had complete success and achieved an unmedicated IOP <21 mmHg. Ninety (90.1%) of eyes were qualified successes (with or without topical medications). Seventy-four (74.7%) eyes have achieved an intraocular pressure of <15 mmHg. Two cases of hypotony were observed.
Conclusion: This study presents a safe surgical technique, which significantly reduces IOP and number of medications with minimal complications.
© 2021. Crown.