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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Validity and generalisability of the studies

    • The studies include adults, young people, and children. Corneal neurotisation may have a different efficacy/safety profile when performed in people of different ages.

    • There were several differences in the type of technique used by the studies. It is unclear which technique provides the most favourable outcomes. The differences included:

      • Type of nerve graft. The sural nerve, great auricular nerve, lateral antebrachial nerve, and an acellular nerve allograft were all used.

      • Coaptation technique. End-to-end and end-to-side coaptation were both used.

      • Donor nerve. Multiple donor nerves were described, including the orbital nerves (supratrochlear, supraorbital, and infraorbital nerves), and the great auricular nerve. There were also differences in the laterality of the donor nerve.

      • Fascicle placement. Some studies used corneoscleral tunnel incisions.

    • The studies that conducted statistical analyses did not report adjustment for multiple comparisons. Testing many hypotheses without adjustment for multiple comparisons increases the likelihood of finding a statistically significant difference between data that is only different due to chance.

    • The studies had small sample sizes, with the largest, Sweeney (2020), including 17 people who had indirect corneal neurotisation.

    • The maximum follow up was 2 years. All studies had a follow up of 6 months to 2 years. This is appropriate to the procedure as some level of corneal sensation is usually recovered after 6 months.

    • One study, a non-randomised controlled trial (Fogagnolo [2020]), enrolled a concurrent control group. Two studies, Capatano (2019) and Sweeney (2020), had a quasi-experimental before-and-after design. The other studies were either case series or case reports and did not perform any comparative statistical analysis.