Department of Ophthalmology, University Hospital of Cologne, Kerpener Str. 62, 50924, Cologne, Germany.
Institute of Medical Statistics and Computational Biology, University Hospital of Cologne, Kerpener Str. 62, 50924, Cologne, Germany.
Adv Ther. 2018 Dec;35(12):2152-2166. doi: 10.1007/s12325-018-0826-6. Epub 2018 Nov 17.
To compare the transconjunctival sutureless 23 gauge (G) pars plana vitrectomy (PPV) with 20 G PPV regarding inflammation, safety, visual outcome and patient comfort.
We included 103 patients with symptomatic macular hole or macular pucker, scheduled for vitrectomy in this prospective, randomized, controlled, mono-center clinical trial. Patients were randomized 1:1 to either 20G PPV (n = 51) or 23G PPV (n = 52). All eyes underwent standard 20G or 23G PPV with membrane peeling. Primary outcome measure was change in aqueous humor flare 3 weeks after surgery compared with baseline. Secondary outcome measures were flare values 2 days and 26 weeks after surgery, subjective discomforts measured with a visual analog scale, best-corrected visual acuity, duration of surgery, intraocular pressure (IOP) and adverse events.
There was no significant difference in change of flare 3 weeks after PPV [- 1.7, 95% CI (- 6.3 to 2.9), p = 0.466]. Both groups showed a significant increase in flare 2 days after surgery (20G: p < 0.001, 23G: p = 0.002), but only the 20G group after 3 weeks (p = 0.011). The gain in visual acuity after 3 weeks was higher after 23G PPV (4.2 95% CI (0.4-8.0, p = 0.029), but without a difference after 6 months. The duration of surgery was shorter in the 23G group (p < 0.001). Patient comfort 3 weeks after surgery was greater after 23G PPV (foreign body sensation p = 0.002; itching: p = 0.021). However, the rate of complications did not differ between the groups.
The primary aim, showing the superiority of the 23G group regarding the change of flare value from baseline to 3 weeks after surgery, was not met, but the level of inflammation decreased faster after 23G PPV. Clear advantages of the 23G PPV were a lower risk of postoperative IOP elevation, a shorter surgery time, faster visual recovery and greater patient comfort in the early postoperative phase.
ClinicalTrials.gov NCT01969929.
比较经结膜无缝 23 号（G）巩膜切开玻璃体切除术（PPV）与 20 G PPV 在炎症、安全性、视力结果和患者舒适度方面的差异。
我们纳入了 103 例患有症状性黄斑裂孔或黄斑前膜的患者，这些患者计划接受玻璃体切除术，进行了这项前瞻性、随机、对照、单中心临床试验。患者按照 1:1 随机分为 20 G PPV 组（n=51）或 23 G PPV 组（n=52）。所有患者均接受标准的 20 G 或 23 G PPV 联合膜剥除术。主要观察指标为术后 3 周与基线相比房水闪辉的变化。次要观察指标为术后 2 天和 26 周时的闪辉值、视觉模拟评分法测量的主观不适、最佳矫正视力、手术时间、眼内压（IOP）和不良事件。
PPV 术后 3 周时，两组的房水闪辉变化无显著差异[-1.7，95%置信区间（-6.3 至 2.9），p=0.466]。两组术后 2 天的闪辉均显著增加（20 G：p<0.001，23 G：p=0.002），但仅 20 G 组在 3 周时增加（p=0.011）。术后 3 周时，23 G PPV 组视力提高（4.2，95%置信区间（0.4-8.0），p=0.029），但 6 个月后无差异。23 G 组的手术时间更短（p<0.001）。术后 3 周时，23 G PPV 组患者的舒适度更高（异物感：p=0.002；瘙痒：p=0.021）。然而，两组的并发症发生率无差异。
主要目的是证明 23 G 组在术后 3 周时的房水闪辉值变化方面优于 20 G 组，但未达到这一目的，但是 23 G PPV 后炎症水平下降更快。23 G PPV 的明显优势在于术后眼压升高的风险较低、手术时间较短、视力恢复较快、术后早期患者舒适度更高。
ClinicalTrials.gov NCT01969929。
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