Department of Eye and Vision Science, University of Liverpool, Liverpool, UK.
Manchester Royal Eye Hospital, Manchester, UK.
Eye (Lond). 2022 Oct;36(10):1905-1910. doi: 10.1038/s41433-021-01737-1. Epub 2021 Sep 20.
To describe a surgical technique and early post-operative outcomes for a novel glaucoma drainage device-the PAUL® glaucoma implant (PGI).
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.
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.
This study presents a safe surgical technique, which significantly reduces IOP and number of medications with minimal complications.
描述一种新型青光眼引流装置——PAUL®青光眼植入物（PGI）的手术技术和术后早期结果。
对 2019 年 2 月至 2020 年 5 月期间接受 PGI 手术且随访时间至少 6 个月的患者进行连续队列研究。主要观察指标包括失败（眼压（IOP）>21mmHg 或 IOP 降低<20%、植入物取出、进一步青光眼干预或视力丧失至无光感）。次要观察指标包括平均 IOP、平均用药数量、对数视力（VA）和并发症。
97 例患者的 99 只眼术前 IOP（均值±标准差）为 28.1±9.0mmHg，术后 1 个月时降至 18.2±6.8mmHg，术后 3 个月时降至 17.9±6.7mmHg，术后 6 个月时降至 13.6±4.7mmHg。52 例患者术后 12 个月平均 IOP 为 13.3±4.4mmHg。平均用药数量减少 2.38±1.48。PGI 后眼压和用药数量显著减少（p<0.0001）。VA 无显著变化（p=0.1158）。共有 9 例被认为是失败（6 例 IOP 较基线降低<20%，3 例 IOP>21mmHg）。38 只（38.4%）眼完全成功，实现无需药物治疗的 IOP<21mmHg。90 只（90.1%）眼为合格成功（有或无局部用药）。74 只（74.7%）眼的 IOP<15mmHg。观察到 2 例低眼压。
本研究提出了一种安全的手术技术，可显著降低眼压和用药数量，且并发症少。
