Pillunat Karin R, Kretz Florian T A, Koinzer Stefan, Müller Philipp, Pillunat Lutz E, Klabe Karsten
Department of Ophthalmology, Medical Faculty Carl Gustav Carus, Technical University, Fetscherstrasse 74, 01307, Dresden, Germany.
Precise Vision Augenärzte, Augentagesklinik Rheine, Osnabrücker Str. 233-235, 48429, Rheine, Germany.
Lasers Med Sci. 2024 Dec 15;39(1):293. doi: 10.1007/s10103-024-04252-3.
To report the safety and effectiveness of selective laser trabeculoplasty (SLT) using the SLT mode of the VISULAS green laser in patients with primary open-angle glaucoma (POAG). Twelve months results are presented. Retrospective extension in 4 German centers of an initially prospective interventional multicenter 3-month clinical investigation using the VISULAS green SLT (Carl Zeiss Meditec AG, Jena, Germany) in patients with POAG who either needed treatment escalation or commenced treatment and had an IOP ≥ 17mmHg at baseline, with no previous glaucoma or other ocular surgery. Non-overlapping laser spots (100) were applied in a single session to 360° of the trabecular meshwork (TM). Glaucoma medications were not changed up to the 3-month visit. From 3 to 12 months, patients were managed according to routine standard of care. Outcome measures included IOP reduction, further glaucoma interventions, and adverse events from baseline to month 12. 25 eyes of 25 POAG patients (mean age 65.8 ± 8.5; modified intention to treat - mITT -group) were included in the extension study. Six eyes (24%) underwent additional glaucoma treatment or changed glaucoma therapy; the remaining 19 eyes (76%) had stable glaucoma therapy (SGT group) with no further glaucoma intervention or change in glaucoma medications (mean number of preoperative glaucoma medications: 2.3 ± 1.34). In the SGT group, mean baseline IOP (mmHg) was reduced from 20.0 ± 2.11 at baseline to 17.4 ± 3.25 and 16.2 ± 1.83 at 6 to 12 months, respectively (p < 0.0001): 52.6% had ≥ 20% IOP reduction at 12 months. Potential device- or procedure-related adverse events were mild to moderate and resolved without sequelae. SLT performed with the VISULAS green laser reduced IOP in eyes with POAG up to 12 months with no relevant safety issues. The results are comparable to other reported SLT studies.
报告使用VISULAS绿色激光的选择性激光小梁成形术（SLT）模式治疗原发性开角型青光眼（POAG）患者的安全性和有效性。本文展示了12个月的研究结果。这是一项在德国4个中心进行的回顾性研究，最初是一项前瞻性介入性多中心3个月临床研究的延伸，该研究使用VISULAS绿色SLT（卡尔·蔡司医疗技术股份公司，德国耶拿）治疗需要升级治疗或开始治疗且基线眼压≥17mmHg、既往无青光眼或其他眼科手术史的POAG患者。在单次治疗中，对小梁网（TM）360°范围应用100个不重叠的激光光斑。在3个月随访前青光眼药物治疗方案不变。从3个月到12个月，患者按照常规标准治疗进行管理。观察指标包括从基线到第12个月的眼压降低情况、进一步的青光眼干预措施以及不良事件。25例POAG患者的25只眼（平均年龄65.8±8.5；改良意向性治疗 - mITT -组）纳入了这项延伸研究。6只眼（24%）接受了额外的青光眼治疗或改变了青光眼治疗方案；其余19只眼（76%）接受了稳定的青光眼治疗（SGT组），未进行进一步的青光眼干预或改变青光眼药物治疗（术前青光眼药物平均数量：2.3±1.34）。在SGT组中，平均基线眼压（mmHg）从基线时的20.0±2.11分别降至6至12个月时的17.4±3.25和16.2±1.83（p＜0.0001）：52.6%的患者在12个月时眼压降低≥20%。潜在的与设备或操作相关的不良事件为轻至中度，且无后遗症地自行缓解。使用VISULAS绿色激光进行的SLT在POAG眼中可降低眼压长达12个月，且无相关安全问题。研究结果与其他已报道的SLT研究结果相当。
