METHODS: Treatment-naïve patients with BRVO and macular oedema were included at two centres and randomized 1:1 to three monthly injections of 2.0 mg aflibercept with (Group A) or without (Group B) navigated central laser, followed by aflibercept as needed from month 4 through 12. Re-treatment need was evaluated, and secondary endpoints included functional and anatomical outcomes and safety evaluated by retinal microperimetry.
RESULTS: We evaluated 41 eyes of 41 patients with a mean age of 69.6 years. Baseline median best-corrected visual acuity (BCVA) was 70.0 letters, and median central retinal thickness (CRT) was 502 μm with no difference between Groups A (n = 21) and B (n = 20). Percentage of patients needing re-treatment after month three was 71% and 80% (p = 0.72). At month 12, groups did not differ in number of injections after loading (1 versus 2, p = 0.43), change in BCVA (+12.8 versus +15.1 letters, p = 0.48), CRT (-195 versus -181 μm, p = 0.82), or retinal sensitivity (+3.3 versus +4.1 dB, p = 0.67).
CONCLUSIONS: In treatment-naïve BRVO patients, addition of navigated central laser to aflibercept did not lower treatment burden or affect functional or anatomical outcomes. A low number of intravitreal injections were needed for successful outcome in both treatment arms.
方法:在两个中心纳入初治BRVO和黄斑水肿的患者,随机1:1至3个月注射2.0mg阿柏西普(A组)或不(B组)导航中央激光,从4到12个月,根据需要进行aflibercept。评估了再治疗需求,次要终点包括功能和解剖学结局以及通过视网膜微视野法评估的安全性.
结果:我们评估了41例患者的41只眼,平均年龄为69.6岁。基线中位数最佳矫正视力(BCVA)为70.0个字母,中位中央视网膜厚度(CRT)为502μm,A组(n=21)和B组(n=20)之间无差异。3个月后需要再次治疗的患者比例分别为71%和80%(p=0.72)。在第12个月,各组在负荷后的注射次数没有差异(1对2,p=0.43),BCVA的变化(+12.8对+15.1个字母,p=0.48),CRT(-195对-181μm,p=0.82),或视网膜灵敏度(+3.3对+4.1dB,p=0.67)。
结论:在未接受治疗的BRVO患者中,在阿柏西普基础上加用导航中枢激光并没有降低治疗负担或影响功能或解剖学结局.在两个治疗组中需要少量的玻璃体内注射以获得成功的结果。