Department of Ophthalmology, University Hospital Basel, Basel, Switzerland.
Institute of Molecular and Clinical Ophthalmology Basel (IOB), Basel, Switzerland.
Ophthalmic Res. 2023;66(1):1362-1375. doi: 10.1159/000535276. Epub 2023 Nov 16.
The aim of this study was to describe and evaluate double PreserFlo MicroShunt implantation as a modified micro-invasive glaucoma surgery technique and to retrospectively compare the outcomes in a cohort of glaucoma patients with single or double implantation.
A retrospective data analysis of 57 glaucoma patients who consecutively underwent PreserFlo implantation was performed. Medical records were examined for patients' demographics, glaucoma type, intraocular pressure (IOP), medication, complications, and re-interventions. Two groups with single (n = 29) or double (n = 28) implantation were formed, and the outcomes were compared. In cases of two-stage double implantation (n = 17), the courses of the initial and the second implantations were compared.
Mean preoperative IOP was significantly higher in the double compared to the single implantation group (29.4 ± 10.0 mm Hg; 21.7 ± 8.2 mm Hg; p = 0.003). Postoperatively, IOP was significantly lower in the double implantation group at various time-points (day 1, week 1, months 3 and 6; all p < 0.021). In the subgroup with two-stage procedures, mean preoperative IOP was 24.5 ± 8.5 mm Hg and 29.8 ± 10.1 mm Hg, respectively (p = 0.128). While immediately postoperatively, mean IOP lowering was clinically significant and similar following both procedures, the longer sustainable effect was observed after the second procedure (month 12: 25.5 ± 7.5 mm Hg; 12.4 ± 4.8 mm Hg; p = 0.001). No serious complications were observed.
DISCUSSION/CONCLUSION: Double PreserFlo implantation appears safe and efficient for lowering IOP in glaucoma patients. Our preliminary findings suggest that double is superior to single implantation in terms of IOP lowering and the need for additional topical medication. Patients with insufficient IOP lowering following single implantation may benefit from a second implantation. Further research is warranted to evaluate double implantation as a first-line, one-stage procedure.
本研究旨在描述和评估双 PreserFlo MicroShunt 植入作为一种改良的微创青光眼手术技术，并回顾性比较单眼和双眼植入的青光眼患者的结果。
对连续接受 PreserFlo 植入的 57 例青光眼患者进行回顾性数据分析。检查了病历中的患者人口统计学、青光眼类型、眼压（IOP）、药物、并发症和再干预情况。将单眼（n=29）或双眼（n=28）植入的两组患者进行比较，并对结果进行比较。在两阶段双植入（n=17）的情况下，比较了初始和第二次植入的过程。
双眼植入组的平均术前 IOP 明显高于单眼植入组（29.4±10.0mm Hg；21.7±8.2mm Hg；p=0.003）。术后，双眼植入组在各个时间点（第 1 天、第 1 周、第 3 个月和第 6 个月）的 IOP 均明显降低（均 p < 0.021）。在两阶段手术的亚组中，平均术前 IOP 分别为 24.5±8.5mmHg 和 29.8±10.1mmHg（p=0.128）。虽然术后即刻，两种手术的平均 IOP 降低都具有显著的临床意义，但第二次手术后的持续效果更好（第 12 个月：25.5±7.5mmHg；12.4±4.8mmHg；p=0.001）。未观察到严重并发症。
讨论/结论：双眼 PreserFlo 植入术在降低青光眼患者的 IOP 方面似乎是安全有效的。我们的初步发现表明，在降低 IOP 和需要额外局部药物治疗方面，双眼植入优于单眼植入。单眼植入后 IOP 降低不足的患者可能受益于第二次植入。需要进一步研究来评估双眼植入作为一线、单阶段手术。
