PDF(Pubmed)
Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：临床前验证研究，以评估电磁图像引导系统（EM-IGS）在眼眶手术中使用高保真物理眼眶解剖模拟器的可行性和准确性。
方法：EM-IGS平台，临床软件,在皇家维多利亚眼耳医院的模拟手术室中评估了导航仪器和参考系统（StealthStationS8，Medtronic），都柏林的一家三级学术医院，爱尔兰。五个高分辨率3D打印模型头骨是使用CT扫描创建的五名匿名患者的眼眶肿瘤，这些患者先前已成功进行了眼眶活检或切除。评估了眼科外科医生在每个模型中实现令人满意的系统配准的能力。随后，使用定义的解剖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。
结果：三名独立的外科医生参与了这项研究，一名初级实习生，一个同事和一个顾问。跨模型，更多的高级参与者能够在更少的尝试次数中实现更小的系统生成的注册错误。在评估导航精度时，大多数点都达到了亚毫米精度(每个模型有16个地标，每位参与者)。定性外科医生的反馈建议该技术的可接受性，尽管注意到手术区域附近的手机干扰。
结论：这项研究表明EM-IGS在一项临床前验证研究中的可行性和准确性，该研究使用患者特定的3D打印头骨进行眼眶手术。该临床前研究为临床研究探索该技术的安全性和有效性提供了基础。
方法：EM-IGS平台，临床软件,在皇家维多利亚眼耳医院的模拟手术室中评估了导航仪器和参考系统（StealthStationS8，Medtronic），都柏林的一家三级学术医院，爱尔兰。五个高分辨率3D打印模型头骨是使用CT扫描创建的五名匿名患者的眼眶肿瘤，这些患者先前已成功进行了眼眶活检或切除。评估了眼科外科医生在每个模型中实现令人满意的系统配准的能力。随后，使用定义的解剖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。
结果：三名独立的外科医生参与了这项研究，一名初级实习生，一个同事和一个顾问。跨模型，更多的高级参与者能够在更少的尝试次数中实现更小的系统生成的注册错误。在评估导航精度时，大多数点都达到了亚毫米精度(每个模型有16个地标，每位参与者)。定性外科医生的反馈建议该技术的可接受性，尽管注意到手术区域附近的手机干扰。
结论：这项研究表明EM-IGS在一项临床前验证研究中的可行性和准确性，该研究使用患者特定的3D打印头骨进行眼眶手术。该临床前研究为临床研究探索该技术的安全性和有效性提供了基础。
