不锈钢青光眼引流植入物（Ex-PRESS）在与白内障超声乳化联合手术中对眼压的长期影响。
Long term effect on IOP of a stainless steel glaucoma drainage implant (Ex-PRESS) in combined surgery with phacoemulsification.
作者信息
Traverso C E, De Feo F, Messas-Kaplan A, Denis P, Levartovsky S, Sellem E, Badalà F, Zagorski Z, Bron A, Gandolfi S, Belkin M
机构信息
DiNOG, Clinica Oculistica, University of Genova, Italy.
出版信息
Br J Ophthalmol. 2005 Apr;89(4):425-9. doi: 10.1136/bjo.2004.058032.
AIM
To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESS R50) for the surgical treatment of primary open angle glaucoma (POAG) and cataract when combined with phacoemulsification.
METHODS
Clinical, prospective, multicentre, single treatment arm, non-randomised, non-masked study. The Ex-PRESS device was implanted at the limbus under a conjunctival flap. Phacoemulsification cataract extraction and in the bag IOL implantation were performed through clear cornea temporally.
PRIMARY OUTCOME
IOP change; secondary outcomes: side effects and VA changes.
RESULTS
26 eyes of 25 patients were implanted with the device. The mean (SD) follow up was 23.9 (10.4) months and the mean age was 75.1 (7.1) years. 17/26 eyes have more than 3 years of follow up. One case was discontinued because of device removal, one because of death, and three were lost to follow up.
EFFICACY
preoperative IOP was 21 (4) mm Hg; at 1, 2, and 3 years IOP was 15.3 (3.1) mm Hg (35% reduction), 16.6 (2.7) mm Hg (29% reduction), and 16 (2.6) mm Hg (22% reduction) respectively. Kaplan-Meyer determined overall success rate (IOP < or = 21 mm Hg at the last visit with or without medications) as 76.9%. The number of antiglaucoma medications was reduced by 95% at year 1. Only six patients (23%) were taking IOP lowering treatment at their last visit, five with one medication and one with two medications. Side effects: early postoperative complications were clinically mild and included six cases of hypotony (IOP <5 mm Hg), three cases of hyphaema (<2 mm) with no clinically significant further effects. Long term complications were two cases (7.7%) of device rotation (one treated by reposition) and three cases (11.5%) of conjunctival erosion at 2 and 3 years.
CONCLUSIONS
The Ex-PRESS implant, combined with phacoemulsification cataract extraction, is clinically safe and effective, maintaining in the long term a large reduction in IOP and in the number of antiglaucoma medications.
目的
评估一种不锈钢微型青光眼引流装置（Ex-PRESS R50）联合超声乳化白内障吸除术治疗原发性开角型青光眼（POAG）合并白内障的有效性和安全性。
方法
临床、前瞻性、多中心、单治疗组、非随机、非盲法研究。Ex-PRESS装置植入于结膜瓣下的角膜缘处。经颞侧透明角膜行超声乳化白内障摘除及囊袋内人工晶状体植入术。
主要观察指标
眼压变化；次要观察指标：副作用及视力变化。
结果
25例患者的26只眼植入了该装置。平均（标准差）随访时间为23.9（10.4）个月，平均年龄为75.1（7.1）岁。26只眼中有17只随访时间超过3年。1例因取出装置而中断随访，1例因死亡中断随访，3例失访。
有效性
术前眼压为21（4）mmHg；1年、2年和3年时眼压分别为15.3（3.1）mmHg（降低35%）、16.6（2.7）mmHg（降低29%）和16（2.6）mmHg（降低22%）。Kaplan-Meyer法确定的总体成功率（末次随访时眼压≤21mmHg，无论是否使用药物）为76.9%。1年时抗青光眼药物数量减少了95%。末次随访时只有6例患者（23%）接受降眼压治疗，5例使用一种药物，1例使用两种药物。副作用：术后早期并发症临床症状较轻，包括6例低眼压（眼压<5mmHg），3例前房积血（<2mm），未产生具有临床意义的进一步影响。长期并发症为2例（7.7%）装置旋转（1例经复位治疗），2年和3年时3例（11.5%）结膜糜烂。
结论
Ex-PRESS植入物联合超声乳化白内障吸除术在临床上安全有效，长期维持眼压大幅降低及抗青光眼药物数量减少。
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