Purpose

Robotic-assisted orbital surgery lacks an established translational pathway. No integrated framework specifies the safety, feasibility, and evaluative requirements needed for responsible early-stage development.

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Methods

A multi-round Delphi process integrated IDEAL stages 0–2a with early health technology assessment (HTA) principles. A ten-member multidisciplinary working group generated thematic domains through qualitative inquiry, producing statements rated by thirty-seven international orbital surgeons on a seven-point Likert scale. Consensus was defined as ≥80% agreement.

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Results

Consensus was reached on progressive preclinical validation (anatomical phantoms, cadaveric procedures, predefined stopping rules), restriction of first-in-human cases to consenting adults, technical feasibility defined as procedural completion without unplanned conversion, and a risk-mitigation bundle (force limiting, emergency stop, simulation training, proctored introduction, inter-centre reporting). Proposed indications including orbital fracture reconstruction, thyroid eye disease decompression, and revision surgery were rejected. Patient-reported outcomes were not endorsed as mandatory early endpoints.

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Conclusion

This study provides the first consensus-based, IDEAL-early HTA framework for robotic-assisted orbital surgery, establishing minimum conditions for responsible translation. It prioritises safety engineering, feasibility assessment, and governance infrastructure over indication-led momentum, offering defensible guidance for clinicians, developers, and regulators.

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Additional Authors

First name	Last name	Base Hospital / Institution
Claire	Daniel	Moorfields Eye Hospital
Jimmy	Uddin	Moorfields Eye Hospital
Christos	Bergelese	Kings College London
Jean-Pierre	Jeannon	Guy’s and St Thomas’ Hospital
Asit	Arora	Guy’s and St Thomas’ Hospital
Robotic Assisted Orbital Surgery	Consortium	International

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