Purpose

To compare vitreous substitution with sulfur hexafluoride (SF6) gas to balanced salt solution (BSS) for the prevention of postoperative vitreous hemorrhage (VH) in proliferative diabetic retinopathy (PDR) patients undergoing pars plana vitrectomy (PPV) for the indication of non-clearing VH.

Methods

One hundred forty-four PDR subjects requiring PPV for the indication of non-clearing VH were enrolled into the trial. Subjects were prospectively randomized into 1 of 2 vitreous substitution groups: Group A subjects underwent 20% to 30% SF6 gas tamponade, whereas Group B subjects underwent vitreous substitution with BSS. The primary outcome was the incidence of postoperative VH during the 6-month trial period. Secondary outcomes were unplanned PPV for VH and best corrected visual acuity (BCVA) at 6-months follow-up.

Results

Ninety-six subjects underwent randomization and completed 6-months follow-up. Postoperative VH during the trial period occurred in 6 of 54 subjects in Group A (SF6) (11.1%) and 14 of 42 in Group B (BSS) (33.3%) (P = .008). Unplanned PPV during the trial period for postoperative VH occurred in 2 of 54 in Group A (3.7%) and 6 of 42 in Group B (14.2%) (P = .06). The mean BCVA was not significantly different at 6-months follow-up between groups (P = .58).

Conclusions

This trial indicates that vitreous substitution with SF6 gas lowers the incidence of postoperative VH compared with BSS in PDR subjects undergoing PPV for the indication of non-clearing VH at 6-months follow-up. Specialists may consider SF6 gas tamponade during PPV as a means of helping reduce postoperative VH in this patient population. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.

中文翻译：

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用于预防糖尿病玻璃体切除术后玻璃体出血的气体填塞：一项随机临床试验

目的

比较用六氟化硫 (SF6) 气体替代玻璃体与平衡盐溶液 (BSS) 预防增殖性糖尿病视网膜病变 (PDR) 患者接受玻璃体切除术 (PPV) 的术后玻璃体出血 (VH) VH。

方法

144 名需要 PPV 以指示非清除 VH 的 PDR 受试者参加了试验。受试者被前瞻性随机分为 2 个玻璃体置换组中的 1 个：A 组受试者接受 20% 至 30% SF6 气体填塞，而 B 组受试者接受 BSS 玻璃体置换。主要结果是 6 个月试验期间术后 VH 的发生率。次要结局是 6 个月随访时 VH 的计划外 PPV 和最佳矫正视力 (BCVA)。

结果

96 名受试者被随机分组​​并完成了 6 个月的随访。在试验期间，A 组 54 名受试者中有 6 名 (SF6) (11.1%) 和 B 组 (BSS) 42 名受试者中有 14 名 (33.3%) 发生术后 VH ( P  = .008)。在 A 组 54 人中的 2 人（3.7%）和 B 组 42 人中的 6 人（14.2%）在术后 VH 试验期间发生了计划外 PPV（P  = .06）。在 6 个月的随访中，各组之间的平均 BCVA 没有显着差异（P  = .58）。

结论

该试验表明，与 BSS 相比，用 SF6 气体进行玻璃体置换可降低接受 PPV 的 PDR 受试者术后 VH 的发生率，以指示在 6 个月的随访中出现非清除 VH。专家可能会考虑在 PPV 期间将 SF6 气体填塞作为帮助减少该患者群体术后 VH 的一种手段。注：本文的出版由美国眼科学会赞助。