Clinical results with the trabectome for treatment of open angle glaucoma
Clinical results with the trabectome for treatment of open angle glaucoma
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DOI：
10.1016/j.ophtha.2004.12.043
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发表时间：
2005-06-01
期刊：
影响因子：
13.7
通讯作者：
Francis, BA
中科院分区：
文献类型：
--
作者：
Minckler, DS;Baerveldt, G;Francis, BA
目的：描述一种新型青光眼手术装置的初步研究的临床结果。设计：前瞻性介入病例系列。参与者：37名成年西班牙裔和白人患者（17名男性，20名女性）患有单眼或双眼未控制的开角型青光眼（OAG），既往有或未做过手术或激光治疗，来自墨西哥蒂华纳的一家临床诊所。干预：使用trabecome （NeoMedix Corp., San Juan Capistrano， CA）对每位患者的一只眼睛进行手术。主要观察指标：术前、术后测量Goldmann压、眼内压和Snellen视力。将术中、术后不良事件制成表格，并比较术前、术后辅助用药次数。结果：药物洗脱1周后的术前压力平均为28.2±4.4 mmHg （n = 37）。仅有3例患者术前未使用局部药物。随访时间为3个月（n = 37）至13个月（n = 11）。术后平均IOPs在1天为18.4 +/- 10.9 mmHg (n = 37)， 1周为17.5 +/- 5.9 mmHg (n = 37)， 6个月为17.4 +/- 3.5 mmHg (n = 25)， 12个月为16.3 +/- 2.0 mmHg （n = 15）。所有患者的视力均恢复到术前2线以内，术后3周后保持稳定，但有1例患者手术时未缝合，其晚期前房积血可能与意外钝性创伤后角膜创口裂开有关。辅助用药次数从术前接受药物治疗的患者（n = 34）的1.2 +/- 0.6次减少到6个月时所有患者（n = 25）的0.4 +/- 0.6次。斜角手术后取下器械时，所有眼睛都出现了血液反流，22只眼睛（59%）在术后第1天出现了血液反流，平均术后6.4 +/- 4.1天通过裂隙灯检查清除。结论：trabecome似乎是降低OAG患者IOP的一种安全有效的方法。
Objective: To describe clinical results from a pilot study of a novel glaucoma surgical device.Design: Prospective interventional case series.Participants: Thirty-seven adult Hispanic and Caucasian patients (17 male, 20 female) with uncontrolled open-angle glaucoma (OAG) in one or both eyes with or without previous surgery or laser treatment were recruited from a clinical practice in Tijuana, Mexico.Intervention: Surgery was performed with the Trabectome (NeoMedix Corp., San Juan Capistrano, CA) in one eye of each patient.Main Outcome Measures: Goldmann applanation intraocular pressures and Snellen visual acuities were measured before and after surgery. Intraoperative and postoperative adverse events were tabulated, and numbers of preoperative and postoperative adjunctive medications were compared before and after surgery.Results: Preoperative pressures after 1 week of medication washout averaged 28.2 +/- 4.4 mmHg (n = 37). Only 3 patients were not using topical medications preoperatively. Follow-up ranged between 3 months (n = 37) and 13 months (n = 11). Mean postoperative IOPs were 18.4 +/- 10.9 mmHg (n = 37) at 1 day, 17.5 +/- 5.9 mmHg (n = 37) at 1 week, 17.4 +/ -3.5 mmHg (n = 25) at 6 months, and 16.3 +/- 2.0 mmHg (n = 15) at 12 months. Visions returned to within 2 lines of preoperative levels and remained stable in all patients beyond 3 weeks postoperatively except one, not sutured at surgery, who had a late hyphema probably associated with corneal wound gaping after accidental blunt trauma. The number of adjunctive medications decreased from 1.2 +/- 0.6 among preoperative patients on medications (n = 34) to 0.4 +/- 0.6 among all patients at 6 months (n = 25). Blood reflux occurred in all eyes on instrument withdrawal after angle surgery and was present at day 1 in 22 eyes (59%) with clearing by slit-lamp examination at a mean of 6.4 +/- 4.1 days postoperatively.Conclusions: The Trabectome seems to offer a safe and effective method of lowering IOP in OAG.