Royal Victoria Eye and Ear Hospital, Dublin, Ireland
RCSI University of Medicine and Health Sciences, Dublin, Ireland.
BMJ Open Ophthalmol. 2024 Apr 4;9(1):e001568. doi: 10.1136/bmjophth-2023-001568.
Preclinical validation study to assess the feasibility and accuracy of electromagnetic image-guided systems (EM-IGS) in orbital surgery using high-fidelity physical orbital anatomy simulators.
EM-IGS platform, clinical software, navigation instruments and reference system (StealthStation S8, Medtronic) were evaluated in a mock operating theatre at the Royal Victoria Eye and Ear Hospital, a tertiary academic hospital in Dublin, Ireland. Five high-resolution 3D-printed model skulls were created using CT scans of five anonymised patients with an orbital tumour that previously had a successful orbital biopsy or excision. The ability of ophthalmic surgeons to achieve satisfactory system registration in each model was assessed. Subsequently, navigational accuracy was recorded using defined anatomical landmarks as ground truth. Qualitative feedback on the system was also attained.
Three independent surgeons participated in the study, one junior trainee, one fellow and one consultant. Across models, more senior participants were able to achieve a smaller system-generated registration error in a fewer number of attempts. When assessing navigational accuracy, submillimetre accuracy was achieved for the majority of points (16 landmarks per model, per participant). Qualitative surgeon feedback suggested acceptability of the technology, although interference from mobile phones near the operative field was noted.
This study suggests the feasibility and accuracy of EM-IGS in a preclinical validation study for orbital surgery using patient specific 3D-printed skulls. This preclinical study provides the foundation for clinical studies to explore the safety and effectiveness of this technology.
使用高保真物理眼眶解剖模拟器对电磁图像引导系统（EM-IGS）在眼眶手术中的可行性和准确性进行临床前验证研究。
在爱尔兰都柏林的三级学术医院皇家维多利亚眼耳医院的模拟手术室中评估 EM-IGS 平台、临床软件、导航仪器和参考系统（StealthStation S8，美敦力）。使用五名患有眼眶肿瘤的匿名患者的 CT 扫描创建了五个高分辨率的 3D 打印模型颅骨，这些患者先前成功进行了眼眶活检或切除。评估眼科外科医生在每个模型中实现令人满意的系统注册的能力。随后，使用定义的解剖学标志作为地面实况记录导航准确性。还获得了对系统的定性反馈。
三名独立的外科医生参与了这项研究，一名初级受训者、一名研究员和一名顾问。在所有模型中，级别较高的参与者能够在较少的尝试中实现较小的系统生成的注册误差。在评估导航准确性时，大多数点（每个模型每个参与者 16 个标志点）都达到了亚毫米级的精度。外科医生的定性反馈表明该技术具有可接受性，尽管手术区域附近的手机干扰被注意到。
这项研究表明，使用患者特异性 3D 打印颅骨进行眼眶手术的 EM-IGS 在临床前验证研究中具有可行性和准确性。这项临床前研究为探索该技术的安全性和有效性的临床研究奠定了基础。
