Institute of Biomedical Engineering, University of Montreal, Montreal, Quebec, Canada.
Maisonneuve-Rosemont Hospital Research Centre, Montreal, Quebec, Canada.
Transl Vis Sci Technol. 2021 Nov 1;10(13):19. doi: 10.1167/tvst.10.13.19.
The occurrence of iatrogenic retinal breaks (RB) in pars plana vitrectomy (PPV) is a complication that compromises the overall efficacy of the surgery. A subset of iatrogenic RB occurs when the retina (rather than the vitreous gel) is cut accidentally by the vitrector. We developed a smart vitrector that can detect in real-time potential iatrogenic RB and activate promptly a PPV machine response to prevent them.
We fabricated the smart vitrectors by attaching a miniaturized fiber-based OCT sensor on commercial vitrectors (25G). The system's response time to an iatrogenic RB onset was measured and compared to the literature reported physiologically limited response time of the average surgeon. Two surgeons validated its ability to prevent simulated iatrogenic RB by performing PPV in pigs. Note that the system is meant to control the PPV machine and requires no visual or audio signal interpretation by the surgeons.
We found that the response time of the system (28.9 ± 6.5 ms) is 11 times shorter compared to the literature reported physiologically limited reaction time of the average surgeon (P < 0.0001). Ex vivo validation (porcine eyes) showed that the system prevents 78.95% (15/19) (95% confidence interval [CI] 54.43-93.95) of intentional attempts at creating RB, whereas in vivo validation showed that the system, prevents 55.68% (30/54) (95% CI 41.40-69.08), and prevents or mitigates 70.37% (38/54) (95% CI 56.39-82.02) of such attempts. A subset of failures was classified as "early stop" (i.e., false positive), having a prevalence of 5.26% (1 /19) in ex vivo tests and 24.07% (13/54) in in vivo tests.
Our results indicate the smart vitrector can prevent iatrogenic RB by providing seamless intraoperative feedback to the PPV machine. Importantly, the use of the smart vitrector requires no modifications of the established PPV procedure. It can mitigate a significant proportion of iatrogenic RB and thus improve the overall efficacy of the surgery.
Potential clinical adoption of the smart vitrector can reduce the incidence of iatrogenic RB in PPV and thus increase the therapeutic outcome of the surgery.
医源性视网膜裂孔（RB）在玻璃体切除术（PPV）中是一种并发症，会影响手术的整体效果。当玻璃体切割器意外切割视网膜（而不是玻璃体凝胶）时，就会出现一部分医源性 RB。我们开发了一种智能玻璃体切割器，可以实时检测潜在的医源性 RB，并迅速激活 PPV 机器响应以防止其发生。
我们通过在商业玻璃体切割器（25G）上附加一个小型纤维基 OCT 传感器来制造智能玻璃体切割器。测量系统对医源性 RB 发作的响应时间，并与文献报道的平均外科医生的生理限制反应时间进行比较。两名外科医生通过在猪身上进行 PPV 来验证其预防模拟医源性 RB 的能力。请注意，该系统旨在控制 PPV 机器，不需要外科医生进行视觉或音频信号解释。
我们发现系统的响应时间（28.9 ± 6.5 ms）比文献报道的平均外科医生的生理限制反应时间（28.9 ± 6.5 ms）短 11 倍（P < 0.0001）。离体验证（猪眼）表明，该系统可预防 78.95%（15/19）（95%置信区间 [CI] 54.43-93.95）的故意 RB 形成尝试，而体内验证表明，该系统可预防 55.68%（30/54）（95%置信区间 [CI] 41.40-69.08），并可预防或减轻 70.37%（38/54）（95%置信区间 [CI] 56.39-82.02）的此类尝试。一部分失败被归类为“早期停止”（即假阳性），在离体试验中的发生率为 5.26%（1/19），在体内试验中的发生率为 24.07%（13/54）。
我们的结果表明，智能玻璃体切割器可以通过向 PPV 机器提供无缝的术中反馈来预防医源性 RB。重要的是，智能玻璃体切割器的使用不需要对现有的 PPV 程序进行修改。它可以减轻相当一部分医源性 RB 的发生，从而提高手术的整体效果。
翻译结果仅供参考，具体内容请以原文为准。
