Department of Ophthalmology, Imam Hossein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.
Am J Ophthalmol. 2010 Jun;149(6):893-902. doi: 10.1016/j.ajo.2010.01.025. Epub 2010 May 8.
To report 2-year follow-up data after Ahmed valve implantation (New World Medical, Inc) and Molteno single-plate implantation surgical treatment of refractory glaucoma.
Prospective, randomized, comparative study.
Patients with refractory glaucoma, defined as uncontrolled intraocular pressure (IOP) of more than 21 mm Hg despite maximal antiglaucoma medication, previously failed nonseton surgical treatment, or a combination thereof were included. Ninety-two patients were allocated randomly to each of the study groups and underwent implantation of either the Ahmed valve implant (model FP7; 184 mm(2) surface area) or Molteno single-plate implant (134 mm(2) surface area) and were followed up for 24 months. Main outcome measures were IOP and surgical success rate. Other outcome measures were changes in visual acuity, number of ant-glaucoma medications, mean deviation of visual field, and rate of intraoperative and postoperative complications.
Those who successfully completed the trial (28 in the Molteno group and 29 in the Ahmed group) achieved significantly less IOP and fewer glaucoma medications, but worse visual acuity 24 months after surgery. The Molteno group, compared with the Ahmed group, achieved significantly lower IOPs after the early postoperative period until the end of the study. Both groups reasonably maintained visual field during the follow-up. The rate of surgical failure was comparable in both groups. Median survival time was 24 months for both groups. There were no devastating intraoperative or postoperative complications in either group.
Both Ahmed and Molteno implants successfully preserved visual field, although IOP control was more pronounced in the Molteno implant group.
报告 Ahmed 阀植入(新视界医疗公司)和 Molteno 单盘植入手术治疗难治性青光眼的 2 年随访数据。
前瞻性、随机、对照研究。
纳入难治性青光眼患者,定义为尽管使用了最大剂量的抗青光眼药物,眼压(IOP)仍超过 21mmHg 且无法控制,先前的非手术治疗失败,或两者兼有。92 例患者随机分配到研究组,分别接受 Ahmed 阀植入(FP7 型;表面积 184mm²)或 Molteno 单盘植入(表面积 134mm²),随访 24 个月。主要观察指标为 IOP 和手术成功率。其他观察指标为视力变化、抗青光眼药物数量、视野平均偏差和术中及术后并发症发生率。
成功完成试验的患者(Molteno 组 28 例,Ahmed 组 29 例)术后 24 个月眼压显著降低,抗青光眼药物减少,但视力下降。与 Ahmed 组相比,Molteno 组在术后早期至研究结束时眼压明显较低。两组在随访期间均能合理维持视野。两组的手术失败率相当。两组的中位生存时间均为 24 个月。两组均无严重的术中或术后并发症。
Ahmed 和 Molteno 植入物均成功地保存了视野,尽管 Molteno 植入物组的眼压控制更为明显。