Seuthe Anna-Maria, Erokhina Mariya, Szurman Peter, Haus Arno
Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany.
J Glaucoma. 2023 May 1;32(5):414-419. doi: 10.1097/IJG.0000000000002178. Epub 2023 Feb 3.
The Preserflo MicroShunt is an effective method to achieve a satisfying intraocular pressure (IOP) reduction in patients with complicated forms of glaucoma.
To evaluate the efficacy and safety of the Preserflo MicroShunt with mitomycin C in patients with complicated glaucoma.
This prospective interventional study included all patients that underwent Preserflo MicroShunt Implantation between April 2019 and January 2021 to treat severe and therapy refractory glaucoma. The patients either suffered from primary open angle glaucoma with already failed incisional glaucoma surgery or presented severe forms of secondary glaucoma (eg, after penetrating keratoplasty or globe penetrating injury). Primary endpoint was the IOP-lowering effect and the success rate after 12 months. Secondary endpoint was the occurrence of intraoperative or postoperative complications. Complete success was defined as reaching the target IOP (>6 mm Hg and <14 mm Hg) without additional IOP-lowering medication whereas qualified success was attained with the same IOP target regardless of the medication.
A total of 40 eyes of 38 patients were enrolled. After 12 months 85.7% of the eyes achieved complete success with an average IOP of 10.5 ± 2.0 mm Hg, without the use of glaucoma eye drops. The average IOP reduction was 58.4% from baseline. In 5 cases (12.5%) failure occurred as revisional surgery was required.
The Preserflo MicroShunt for refractory glaucoma cases achieved a high complete success rate without additional medication at 1 year. Revisional surgery was needed in some cases and long-term studies are needed.
Preserflo微型分流器是一种有效降低复杂型青光眼患者眼压(IOP)的方法。
评估Preserflo微型分流器联合丝裂霉素C治疗复杂型青光眼的疗效和安全性。
这项前瞻性干预性研究纳入了2019年4月至2021年1月期间接受Preserflo微型分流器植入术治疗严重及难治性青光眼的所有患者。这些患者要么患有原发性开角型青光眼且切开性青光眼手术已失败,要么患有严重的继发性青光眼(如穿透性角膜移植术后或眼球穿通伤后)。主要终点是12个月后的眼压降低效果和成功率。次要终点是术中或术后并发症的发生情况。完全成功定义为在不使用额外降眼压药物的情况下达到目标眼压(>6 mmHg且<14 mmHg),而无论是否使用药物,达到相同眼压目标则为合格成功。
共纳入38例患者的40只眼。12个月后,85.7%的患眼完全成功,平均眼压为10.5±2.0 mmHg,未使用青光眼滴眼液。眼压较基线平均降低了58.4%。5例(12.5%)因需要进行翻修手术而失败。
Preserflo微型分流器治疗难治性青光眼病例在1年时无需额外用药即可获得较高的完全成功率。部分病例需要进行翻修手术,还需要长期研究。