Instituto de la Visión-Hospital La Carlota, Nuevo León, México.
Panhandle Eye Group, Amarillo, Texas.
Retina. 2021 Jul 1;41(7):1407-1415. doi: 10.1097/IAE.0000000000003052.
To compare vitreous substitution with silicone oil to perfluoropropane gas in proliferative diabetic retinopathy subjects undergoing pars plana vitrectomy (PPV) for the treatment of tractional retinal detachment or extensive fibrous proliferation.
Randomized clinical trial.
Three hundred and two proliferative diabetic retinopathy subjects with tractional retinal detachment or extensive fibrous proliferation requiring PPV were enrolled into the trial. Subjects were prospectively randomized into one of two vitreous substitution groups during PPV: Group A subjects underwent 1,000 centistoke silicone oil tamponade, whereas Group B subjects underwent 14% to 16% silicone oil to perfluoropropane gas tamponade. The principal outcome was the best-corrected visual acuity at 6-month follow-up. Secondary outcomes were postoperative complications and unplanned PPV during the 6-month trial interval.
Two hundred and fifty-eight subjects were randomized to receive a vitreous substitute and completed 6-month follow-up. Group B had better best-corrected visual acuity, more subjects ending up with 0.4 logarithm of the minimum angle of resolution (20/50) or better visual acuity, and more subjects ending up with 1 logarithm of the minimum angle of resolution (20/200) or better visual acuity at 6 months compared with Group A (P < 0.001, P = 0.02, P < 0.001, respectively). There were no significant differences in baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV between groups.
This trial demonstrated that vitreous substitution with silicone oil to perfluoropropane gas resulted in better visual acuity at 6 months compared with silicone oil tamponade in proliferative diabetic retinopathy patients undergoing PPV for tractional retinal detachment or extensive fibrous proliferation. Surgeons should consider silicone oil to perfluoropropane gas tamponade as the first-line vitreous substitute in this patient population.
比较在接受增生性糖尿病视网膜病变患者行玻璃体切除术（PPV）治疗牵拉性视网膜脱离或广泛纤维增生时，玻璃体替代物与硅油和全氟丙烷气体的疗效。
随机临床试验。
本试验纳入了 302 名患有牵拉性视网膜脱离或广泛纤维增生、需要行 PPV 的增生性糖尿病视网膜病变患者。在 PPV 过程中，患者前瞻性随机分为两组玻璃体替代物组：A 组患者行 1000 厘沲硅油填充，B 组患者行 14%至 16%硅油与全氟丙烷气体填充。主要结局是 6 个月随访时的最佳矫正视力。次要结局是术后并发症和 6 个月试验期间的计划性外 PPV。
258 名患者随机接受玻璃体替代物治疗并完成了 6 个月随访。B 组患者的最佳矫正视力更好，有更多的患者术后达到 0.4 对数最小分辨角视力（20/50）或更好的视力，有更多的患者术后达到 1 对数最小分辨角视力（20/200）或更好的视力，与 A 组相比差异有统计学意义（P < 0.001、P = 0.02、P < 0.001）。两组患者的基线特征、术中或术后并发症以及计划性外 PPV 的发生率均无显著差异。
本试验表明，在接受增生性糖尿病视网膜病变患者行 PPV 治疗牵拉性视网膜脱离或广泛纤维增生时，玻璃体替代物与硅油和全氟丙烷气体填充相比，可在 6 个月时获得更好的视力。对于该患者人群，外科医生应考虑将硅油与全氟丙烷气体填充作为一线玻璃体替代物。
