Save Sight Institute, the University of Sydney, Sydney, Australia.
Ophthalmology. 2011 May;118(5):866-72. doi: 10.1016/j.ophtha.2010.09.029. Epub 2011 Jan 12.
To report the 24 months outcomes from a clinical trial of intravitreal triamcinolone acetonide (IVTA) plus laser versus laser treatment only in eyes with diabetic macular edema (DME).
Prospective, double-masked, randomized, placebo-controlled study.
Eighty-four eyes of 54 participants were entered into the study, with 42 eyes randomly assigned to receive IVTA plus laser and 42 randomly assigned to receive laser treatment alone. Primary end point data were available for 71 (84.5%) eyes at 24 months, with last visual acuity observation carried forward for the remaining eyes.
Best-corrected logarithm of minimum angle of resolution (logMAR) visual acuity and central macular thickness (CMT) by optical coherence tomography were measured after laser treatment preceded by either IVTA or sham.
The primary outcome was the proportion of eyes with improvement in visual acuity of 10 letters or more at 24 months. The secondary outcomes were mean visual acuity, requirement for further treatment, change in CMT, and adverse events.
At 24 months, improvement of 10 logMAR letters or more was seen in 15 (36%) of 42 eyes treated with IVTA plus laser compared with 7 (17%) of 42 eyes treated with laser only (P = 0.047; odds ratio, 2.79; 95% confidence interval, 1.01-7.67). There was no difference in the mean CMT or mean logMAR visual acuity between 2 groups. At least 1 retreatment was required in the second year of the study in 29 (69%) of 42 IVTA plus laser-treated eyes compared with 19 (45%) of 42 laser only eyes (P = 0.187). Cataracts were removed from 17 (61%) of 28 phakic IVTA plus laser-treated eyes versus 0 (0%) of 27 laser only eyes (P<0.001). Treatment for elevated intraocular pressure was required in 27 (64%) of 42 IVTA plus laser eyes compared with 10 (24%) of 42 laser only eyes (P<0.001).
Treatment with IVTA plus laser resulted in a doubling of improvement in vision by 10 letters or more compared with laser only over 2 years in eyes with DME, but is associated with cataract and raised intraocular pressure.
报告一项关于玻璃体内曲安奈德（IVTA）联合激光与单纯激光治疗糖尿病黄斑水肿（DME）的 24 个月临床试验结果。
前瞻性、双盲、随机、安慰剂对照研究。
54 名患者的 84 只眼入组研究，42 只眼随机分配接受 IVTA 联合激光治疗，42 只眼随机分配接受单纯激光治疗。24 个月时，71 只（84.5%）眼可获得主要终点数据，其余眼的最后视力观察结果向前推进。
在激光治疗前，通过光学相干断层扫描测量最佳矫正视力对数最小分辨角（logMAR）和中心黄斑厚度（CMT）。
主要结局是 24 个月时视力提高 10 个字母或更多的眼的比例。次要结局是平均视力、需要进一步治疗、CMT 变化和不良事件。
24 个月时，IVTA 联合激光治疗的 42 只眼中有 15 只（36%）视力提高 10 logMAR 字母或更多，而单纯激光治疗的 42 只眼中有 7 只（17%）（P = 0.047；优势比，2.79；95%置信区间，1.01-7.67）。两组间平均 CMT 或平均 logMAR 视力无差异。在研究的第二年，至少需要进行第二次治疗的 IVTA 联合激光治疗眼有 29 只（69%），而单纯激光治疗眼有 19 只（45%）（P = 0.187）。在 28 只非白内障 IVTA 联合激光治疗眼中，有 17 只（61%）需要摘除白内障，而在 27 只单纯激光治疗眼中，无 0 只（0%）需要摘除白内障（P<0.001）。需要治疗眼压升高的 IVTA 联合激光治疗眼有 27 只（64%），而单纯激光治疗眼有 10 只（24%）（P<0.001）。
与单纯激光治疗相比，在 2 年内，IVTA 联合激光治疗可使 DME 眼的视力提高 10 个字母或更多的比例增加一倍，但与白内障和眼压升高有关。
