Oftalvist Group, HLA Moncloa Hospital, Madrid.
Oftalvist Group, HLA Vistahermosa Hospital, Alicante, Spain.
J Glaucoma. 2022 Jul 1;31(7):557-566. doi: 10.1097/IJG.0000000000002052. Epub 2022 May 17.
The Preserflo Microshunt (PSM) is a safe and effective glaucoma microfiltering implant that significantly reduces the intraocular pressure (IOP), either alone or in combination with phacoemulsification, during the first year after surgery.
The purpose of this study was to assess the safety and efficacy of the PSM for the treatment of open angle glaucoma with 0.2 mg/mL mitomycin C, either alone or in combination with cataract surgery.
A retrospective, open-label study of 64 eyes with primary open angle glaucoma that underwent PSM implantation and were followed up for at least 9 months. Success was defined as IOP 6-17 mm Hg and a reduction of at least 20%, complete without hypotensive medication, and qualified with medication. Safety was assessed by the incidence of adverse events. Secondary endpoints included mean hypotensive medications, visual acuity, and incidence of needling and surgical revision.
A total of 51 eyes underwent PSM alone and 13 underwent PSM+phacoemulsification. In the overall population of the study, the mean IOP was significantly reduced from 22.03±0.7 mm Hg at baseline to 12.7±0.4 mm Hg at the final visit, P <0.0001 (mean follow-up: 11±1.4 mo). The IOP was significantly reduced in both groups ( P <0.0001). Ocular hypotensive medication was reduced significantly from 2.7±0.7 to 0.2±0.5 ( P <0.0001). No significant differences were found in IOP-lowering medication between groups (PSM alone, 0.2±0.08; PSM+phacoemulsification, 0.1±0.1; P =0.2). At the final visit, 70.3% were considered as complete success and 12.5% as qualified success. The most common adverse event was clinical hypotony (7.8%) followed by hyphema (4.7%), and anterior chamber reformation (1.6%). Overall, 1.6% required needling and 15.6% surgical revision to restore the flow.
Glaucoma surgery with the PSM and mitomycin C was efficacious and safe in the short term, either alone or in combination with cataract surgery, and may be considered a surgical option for lowering IOP in primary open angle glaucoma.
Preserflo 微分流器（PSM）是一种安全有效的青光眼微滤过植入物，在手术后的第一年，无论是单独使用还是与超声乳化白内障吸除术联合使用，都能显著降低眼内压（IOP）。
本研究旨在评估 0.2mg/ml 丝裂霉素 C 单独或联合白内障手术治疗开角型青光眼的 PSM 的安全性和有效性。
对 64 例原发性开角型青光眼患者进行回顾性、开放性 PSM 植入术，并至少随访 9 个月。成功定义为 IOP 为 6-17mmHg，降低至少 20%，完全无需降压药物，并用药物治疗合格。安全性通过不良事件的发生率来评估。次要终点包括平均降压药物、视力和需要针拨术和手术修正的发生率。
共有 51 只眼单独行 PSM，13 只眼行 PSM+超声乳化白内障吸除术。在研究的总体人群中，平均 IOP 从基线时的 22.03±0.7mmHg 显著降低到最后一次就诊时的 12.7±0.4mmHg，P<0.0001（平均随访时间：11±1.4 个月）。两组 IOP 均显著降低（P<0.0001）。眼内压降低药物从 2.7±0.7 显著减少至 0.2±0.5（P<0.0001）。两组间降压药物无显著差异（PSM 单独组 0.2±0.08；PSM+超声乳化白内障吸除术组 0.1±0.1；P=0.2）。最后一次就诊时，70.3%被认为是完全成功，12.5%是合格成功。最常见的不良事件是临床低眼压（7.8%），其次是前房积血（4.7%）和前房重建（1.6%）。总体上，1.6%需要针拨术，15.6%需要手术修正以恢复流量。
PSM 联合丝裂霉素 C 的青光眼手术在短期内是有效和安全的，无论是单独使用还是与白内障手术联合使用，都可以考虑作为降低原发性开角型青光眼眼内压的手术选择。
