Southern California Desert Retina Consultants, Palm Desert, California.
Retinal Consultants of San Antonio, San Antonio, Texas.
Ophthalmology. 2021 Nov;128(11):1592-1603. doi: 10.1016/j.ophtha.2021.05.005. Epub 2021 May 12.
To evaluate pneumatic vitreolysis (PVL) in eyes with vitreomacular traction (VMT) with and without full-thickness macular hole (FTMH).
Two multicenter (28 sites) studies: a randomized clinical trial comparing PVL with observation (sham injection) for VMT without FTMH (Protocol AG) and a single-arm study assessing PVL for FTMH (Protocol AH).
Participants were adults with central VMT (vitreomacular adhesion was ≤3000 μm). In Protocol AG, visual acuity (VA) was 20/32 to 20/400. In Protocol AH, eyes had a FTMH (≤250 μm at the narrowest point) and VA of 20/25 to 20/400.
Pneumatic vitreolysis using perfluoropropane (CF) gas.
Central VMT release at 24 weeks (Protocol AG) and FTMH closure at 8 weeks (Protocol AH).
From October 2018 through February 2020, 46 participants were enrolled in Protocol AG, and 35 were enrolled in Protocol AH. Higher than expected rates of retinal detachment and tear resulted in early termination of both protocols. Combining studies, 7 of 59 eyes (12% [95% CI, 6%-23%]; 2 eyes in Protocol AG, 5 eyes in Protocol AH) that received PVL developed rhegmatogenous retinal detachment (n = 6) or retinal tear (n = 1). At 24 weeks in Protocol AG, 18 of 23 eyes in the PVL group (78%) versus 2 of 22 eyes in the sham group (9%) achieved central VMT release without rescue vitrectomy (adjusted risk difference, 66% [95% CI, 44%-88%]; P< 0.001). The mean change in VA from baseline at 24 weeks was 6.7 letters in the PVL group and 6.1 letters in the sham group (adjusted difference, -0.8 [95% CI, -6.1 to 4.5]; P = 0.77). In Protocol AH, 10 of 35 eyes (29% [95% CI, 16%-45%]) achieved FTMH closure without rescue vitrectomy at 8 weeks. The mean change in VA from baseline at 8 weeks was -1.5 letters (95% CI, -10.3 to 7.3 letters).
In most eyes with VMT, PVL induced hyaloid release. In eyes with FTMH, PVL resulted in hole closure in approximately one third of eyes. These studies were terminated early because of safety concerns related to retinal detachments and retinal tears.
评估伴有和不伴有全层黄斑孔（FTMH）的玻璃体黄斑牵引（VMT）患者的气动玻璃体切割术（PVL）。
两项多中心（28 个地点）研究：一项比较 PVL 与观察（假注射）治疗无 FTMH 的 VMT 的随机临床试验（协议 AG）和一项评估 FTMH 中 PVL 的单臂研究（协议 AH）。
参与者为中央 VMT 成人（玻璃体黄斑粘连≤3000μm）。在协议 AG 中，视力（VA）为 20/32 至 20/400。在协议 AH 中，眼睛有 FTMH（最窄处≤250μm）和 20/25 至 20/400 的 VA。
使用全氟丙烷（CF）气体进行气动玻璃体切割术。
24 周时中央 VMT 释放（协议 AG）和 8 周时 FTMH 闭合（协议 AH）。
2018 年 10 月至 2020 年 2 月，46 名参与者被纳入协议 AG，35 名参与者被纳入协议 AH。视网膜脱离和撕裂的发生率高于预期，导致两项研究提前终止。将两项研究合并，59 只眼中有 7 只（12%[95%CI，6%-23%]；2 只眼在协议 AG，5 只眼在协议 AH）接受 PVL 后发生孔源性视网膜脱离（n=6）或视网膜撕裂（n=1）。在协议 AG 的 24 周时，PVL 组 23 只眼中有 18 只（78%），而假注射组 22 只眼中有 2 只（9%）无需挽救性玻璃体切除术即可实现中央 VMT 释放（调整风险差异，66%[95%CI，44%-88%]；P<0.001）。PVL 组在 24 周时 VA 从基线的平均变化为 6.7 个字母，假注射组为 6.1 个字母（调整差异，-0.8[95%CI，-6.1 至 4.5]；P=0.77）。在协议 AH 中，35 只眼中有 10 只（29%[95%CI，16%-45%]）在 8 周时无需挽救性玻璃体切除术即可实现 FTMH 闭合。8 周时 VA 从基线的平均变化为-1.5 个字母（95%CI，-10.3 至 7.3 个字母）。
在大多数 VMT 眼中，PVL 诱导了玻璃体后脱离。在伴有 FTMH 的眼中，PVL 导致大约三分之一的眼睛孔闭合。由于与视网膜脱离和视网膜撕裂相关的安全性问题，这些研究提前终止。
