Hospital Clínico Universitario San Carlos, Instituto de Investigaciones Ramón Castroviejo, Madrid, Spain.
Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5.
PURPOSE. To evaluate the changes in aqueous humor dynamics and the efficacy and safety of the iStent (Glaukos Corp., Laguna Hills, CA), in combination with cataract surgery. METHODS. This investigation was a prospective, randomized, clinical study in patients with open-angle glaucoma or ocular hypertension who were undergoing cataract surgery. Aqueous flow (F) and trabecular outflow facility (C(T)) were measured by fluorophotometry before surgery and at months 1, 6, and 12 in both groups. RESULTS. Thirty-three eyes of 33 patients were randomized to either two stents and cataract surgery (n = 17, group 1) or cataract surgery alone (n = 16, group 2). Before surgery, F and C(T) were similar in groups 1 and 2 (1.78 +/- 0.44 and 1.74 +/- 0.82 microL/min, P = 0.18; 0.12 +/- 0.03 and 0.13 +/- 0.06 microL/min/mm Hg, P = 0.71, respectively). After surgery, there were no changes of note in F, however, C(T) increased in both groups. At 1 year, C(T) was 0.45 +/- 0.27 microL/min/mm Hg in group 1 and 0.19 +/- 0.05 microL/min/mm Hg in group 2 (P = 0.02), which represented increases of 275% and 46%, respectively. Mean IOP reduction was also greater in group 1 than in group 2 (6.6 +/- 3.0 mm Hg vs. 3.9 +/- 2.7 mm Hg; P = 0.002). The mean number of medications was significantly lower in group 1 than in group 2 (0.0 vs. 0.7 +/- 1.0, respectively; P = 0.007). CONCLUSIONS. Compared with cataract surgery alone, implantation of the iStent concomitant with cataract extraction significantly increased trabecular outflow facility, reduced IOP, and reduced the number of medications at 1 year. Longer follow-up is needed to assess the long-term effect on outflow facility. (ClinicalTrials.gov number, NCT00326066.).
目的。评估 iStent（加利福尼亚州拉古纳山的 Glaukos 公司）联合白内障手术对房水动力学的变化及疗效和安全性。
方法。本研究为前瞻性、随机、临床研究，纳入了行白内障手术的开角型青光眼或高眼压患者。两组患者术前及术后 1、6 和 12 个月时均行荧光光度法测量房水流动（F）和小梁流出阻力（C（T））。
结果。33 例（33 只眼）患者随机分为两组，每组 17 例（组 1）接受 2 枚 iStent 植入联合白内障手术，16 例（组 2）仅行白内障手术。术前两组患者的 F 和 C（T）相似（1.78±0.44 和 1.74±0.82 μL/min，P=0.18；0.12±0.03 和 0.13±0.06 μL/min/mm Hg，P=0.71）。术后 F 无明显变化，但两组 C（T）均增加。1 年时，组 1 的 C（T）为 0.45±0.27 μL/min/mm Hg，组 2 为 0.19±0.05 μL/min/mm Hg（P=0.02），分别增加了 275%和 46%。组 1 的平均眼压（IOP）降低幅度也大于组 2（6.6±3.0 mm Hg 比 3.9±2.7 mm Hg；P=0.002）。组 1 的平均用药数显著低于组 2（0.0 比 0.7±1.0，P=0.007）。
结论。与单纯白内障手术相比，iStent 植入联合白内障摘出可显著增加小梁流出阻力，降低 IOP，并减少术后 1 年的用药数。还需要更长时间的随访来评估对流出阻力的长期影响。（临床试验注册号：NCT00326066）。
