Wittpenn John R, Silverstein Steven, Heier Jeffrey, Kenyon Kenneth R, Hunkeler John D, Earl Melissa
State University of New York at Stony Brook, Stony Brook, New York 11790, USA.
Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.
To evaluate whether adding perioperative topical ketorolac tromethamine 0.4% improves cataract surgery outcomes relative to topical steroids alone in patients without known risk factors for cystoid macular edema (CME).
Prospective, randomized, investigator-masked, multicenter clinical trial.
Patients scheduled to undergo phacoemulsification and with no recognized CME risks (diabetic retinopathy, retinal vascular disease, or macular abnormality) were randomized to receive either prednisolone acetate 1% 4 times daily (QID) alone (steroid group; n = 278) or prednisolone 1% QID plus ketorolac 0.4% QID (ketorolac/steroid group; n = 268) for approximately four weeks postoperatively. In the ketorolac/steroid group, patients also received topical ketorolac 0.4% QID for three days preoperatively. In both groups, patients received four doses of ketorolac 0.4% one hour before surgery. Patients with capsular disruption or vitreous loss intraoperatively were exited from the study. Outcome measures included CME incidence, retinal thickness as measured by optical coherence tomography (OCT), best-corrected visual acuity, and contrast sensitivity.
No patients in the ketorolac/steroid group and five patients in the steroid group had clinically apparent CME (P = .032). Based on OCT, no ketorolac/steroid patient had definite or probable CME, compared with six steroid patients (2.4%; P = .018). In the ketorolac/steroid group, mean retinal thickening was less (3.9 microm vs 9.6 microm; P = .003), and fewer patients had retinal thickening of more than 10 microm as compared with the steroid group (26% vs 51%; P < .001).
This study suggests that adding perioperative ketorolac to postoperative prednisolone significantly reduces the incidences of CME and macular thickening in cataract surgery patients already at low risk for this condition.
评估对于无已知黄斑囊样水肿（CME）风险因素的患者，围手术期添加0.4%的外用酮咯酸氨丁三醇相对于单独使用外用类固醇是否能改善白内障手术的效果。
前瞻性、随机、研究者设盲、多中心临床试验。
计划接受超声乳化手术且无公认CME风险（糖尿病视网膜病变、视网膜血管疾病或黄斑异常）的患者被随机分为两组，一组每天4次单独使用1%醋酸泼尼松龙（类固醇组；n = 278），另一组术后约四周每天4次使用1%醋酸泼尼松龙加0.4%酮咯酸（酮咯酸/类固醇组；n = 268）。在酮咯酸/类固醇组中，患者术前三天也每天4次使用0.4%外用酮咯酸。两组患者在手术前1小时均接受4剂0.4%酮咯酸。术中出现囊膜破裂或玻璃体丢失的患者退出研究。观察指标包括CME发生率、光学相干断层扫描（OCT）测量的视网膜厚度、最佳矫正视力和对比敏感度。
酮咯酸/类固醇组无患者发生临床明显的CME，类固醇组有5例（P = 0.032）。基于OCT，酮咯酸/类固醇组无患者出现明确或可能的CME，而类固醇组有6例（2.4%；P = 0.018）。与类固醇组相比，酮咯酸/类固醇组的平均视网膜增厚较少（3.9微米对9.6微米；P = 0.003），视网膜增厚超过10微米的患者也较少（26%对51%；P < 0.001）。
本研究表明，在术后使用泼尼松龙的基础上围手术期添加酮咯酸可显著降低白内障手术患者中CME和黄斑增厚的发生率，这些患者发生这种情况的风险本来就较低。
