RESUMO
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. CONCLUSION: 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.
