Blindbaek Søren L, Peto Tunde, Grauslund Jakob
Department of Ophthalmology, Odense University Hospital, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Acta Ophthalmol. 2020 Jun;98(4):347-352. doi: 10.1111/aos.14266. Epub 2019 Oct 10.
To examine the efficacy of intravitreal aflibercept and navigated laser as compared to intravitreal aflibercept and conventional laser in diabetic macular oedema (DME) treatment.
In 12-month randomized clinical trial, 48 eyes of 37 patients with centre-involved DME at Odense University Hospital were randomized 1:1 to receive three monthly injections of aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser. From month four through twelve, patients were examined monthly, and additional injections were given pro re nata (PRN) (central retinal thickness [CRT]>20% from lowest measurement or loss in visual acuity [VA]>5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters compared with baseline). Outcome measures; (1) percentage of eyes that needed additional injections after laser in group A and B, (2) mean number of injections in group A and B, and (3) mean change in VA and CRT in group A and B.
In the PRN phase, 60.5% of patients needed additional injections without differences between groups A and B (58.3 versus 63.2%, p > 0.99). The mean number of injections between baseline and month 12 was 4.4 (4.2 versus 4.6, p = 0.41). From baseline to month 12, VA improved by 8.4 ETDRS letters, and CRT was reduced by 97.4 μm (+9.4 versus +7.1 letters, p = 0.17, and -83.2 versus -115.4 μm, p = 0.21).
No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.
比较玻璃体内注射阿柏西普联合导航激光与玻璃体内注射阿柏西普联合传统激光治疗糖尿病性黄斑水肿（DME）的疗效。
在一项为期12个月的随机临床试验中，欧登塞大学医院37例累及中心凹的DME患者的48只眼被1:1随机分组，接受每月3次阿柏西普注射，随后分别接受导航激光（A组）或传统（B组）局灶/格栅激光治疗。从第4个月到第12个月，每月对患者进行检查，根据需要（视网膜中央厚度[CRT]比最低测量值增加>20%或视力[VA]下降>5个早期糖尿病性视网膜病变研究[ETDRS]字母，与基线相比）给予额外注射。观察指标：（1）A组和B组激光治疗后需要额外注射的眼数百分比；（2）A组和B组的平均注射次数；（3）A组和B组VA和CRT的平均变化。
在按需治疗阶段，60.5%的患者需要额外注射，A组和B组之间无差异（58.3%对63.2%，p>0.99）。基线至第12个月的平均注射次数为4.4次（4.2次对4.6次，p=0.41）。从基线到第12个月，VA提高了8.4个ETDRS字母，CRT降低了97.4μm（+9.4个字母对+7.1个字母，p=0.17，-83.2μm对-115.4μm，p=0.21）。
在阿柏西普联合导航激光与传统激光治疗组之间，未检测到再治疗需求的差异。
