Ockrim Z K, Sivaprasad S, Falk S, Roghani S, Bunce C, Gregor Z, Hykin P
Royal Alexander Hospital, Corsebar Road, Paisley PA2 9PN, UK.
Br J Ophthalmol. 2008 Jun;92(6):795-9. doi: 10.1136/bjo.2007.131771. Epub 2008 Apr 17.
To determine if repeated intravitreal triamcinolone improves best corrected visual acuity at 1 year compared with conventional laser therapy for persistent diabetic macular oedema.
88 eyes with persistent clinically significant macular oedema, after at least one prior laser photocoagulation, were included in this prospective randomised controlled trial. 43 patients were randomised to 4 mg of intravitreal triamcinolone (TA) and 45 to laser photocoagulation. The primary endpoint was the proportion of patients who improved by 15 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters at 12 months in TA versus laser groups. Secondary endpoints were the change in mean best corrected visual acuity, difference in macular thickness and macular volume and adverse event reporting in particular elevated intraocular pressure at 12 months.
Improvement in > or =15 ETDRS letters occurred in two of 42 patients in the TA group (4.8%) and in five of 41 (12.2%) patients in the laser group (p = 0.265). At baseline, the mean ETDRS scores at baseline were 54.4 letters in the TA group and 53.0 letters in the laser group. At 12 months, these were 54.5 and 54.6, respectively. Optical coherence tomography showed a reduction in central macular thickness of 82.0 microm with TA and 62.3 microm with laser at 12 months. There was one case of sterile endophthalmitis. 22 out of 43 patients in the triamcinolone group required ocular antihypertensives.
This study did not show a benefit from intravitreal triamcinolone over conventional laser therapy for patients with chronic diabetic macular oedema.
确定与传统激光治疗持续性糖尿病黄斑水肿相比,重复玻璃体内注射曲安奈德在1年时是否能提高最佳矫正视力。
本前瞻性随机对照试验纳入了88只患有持续性临床显著性黄斑水肿且至少接受过一次先前激光光凝治疗的眼睛。43例患者被随机分配接受4mg玻璃体内曲安奈德(TA)治疗,45例患者接受激光光凝治疗。主要终点是TA组和激光组中在12个月时最佳矫正视力提高15个糖尿病视网膜病变早期治疗研究(ETDRS)字母的患者比例。次要终点包括平均最佳矫正视力的变化、黄斑厚度和黄斑体积的差异以及不良事件报告,特别是12个月时的眼压升高情况。
TA组42例患者中有2例(4.8%)最佳矫正视力提高≥15个ETDRS字母,激光组41例患者中有5例(12.2%)最佳矫正视力提高≥15个ETDRS字母(p = 0.265)。基线时,TA组的平均ETDRS分数为54.4个字母,激光组为53.0个字母。12个月时,两组分别为54.5和54.6个字母。光学相干断层扫描显示,12个月时TA组黄斑中心厚度减少82.0微米,激光组减少62.3微米。发生了1例无菌性眼内炎。曲安奈德组43例患者中有22例需要使用眼部降压药。
对于慢性糖尿病黄斑水肿患者,本研究未显示玻璃体内注射曲安奈德比传统激光治疗更具优势。