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    Interventional procedure overview of nerve graft for corneal denervation

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    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.

    Additional papers identified

    Article

    Number of patients/follow up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    Mixed techniques

    Park JK, Charlson ES, Leyngold I et al. (2020) Corneal Neurotization: A Review of Pathophysiology and Outcomes. Ophthalmic plastic and reconstructive surgery 36(5):431-7

    n=54 eyes

    Corneal neurotisation can significantly improve corneal sensation and visual acuity and should be considered for the treatment of refractory neurotrophic keratitis, especially in paediatric populations. No significant differences found between techniques or donor nerves.

    Pools data from people who had nerve graft neurotisation with people who had direct nerve transfer.

    Acellular nerve allograft

    Kim JS, Rafailov L, and Leyngold lM. (2021) Corneal Neurotization for Postherpetic Neurotrophic Keratopathy: Initial Experience and Clinical Outcomes. Ophthalmic plastic and reconstructive surgery 37(1):42-50

    n=2

    FU=11.3 months

    Corneal neurotisation can successfully reinnervate corneas previously devitalised by herpetic disease and halt the progressive nature of postherpetic NK. If utilised appropriately and early in the disease process, neurotisation may reduce morbidity and maximise visual potential in postherpetic NK.

    One of the people included in this study is also included in Leyngold (2019). Statistical analysis is performed on the entire cohort, including 4 people who had direct neurotisation.

    Sural nerve graft

    Bains RD, Elbaz U, Zuker RM, et al. (2015) Corneal neurotization from the supratrochlear nerve with sural nerve grafts: a minimally invasive approach. Plastic and reconstructive surgery 135(2):397e-400e.

    n=10 eyes

    FU=6 months

    Establishment of protective corneal sensation in all people in this series using corneal neurotisation with sural nerve grafts.

    Likely patient population overlap with Catapano, 2019. Technique publication, results insufficiently described.

    Ebner R, Fridrich G, Socolovsky M et al. (2020) In Vivo Corneal Confocal Microscopy: Pre- and Post-operative Evaluation in a Case of Corneal Neurotization. Neuro-Ophthalmology 44(3):193-6

    n=1

    FU=24 weeks

    Paediatric

    Favourable trophic changes were observed at different levels of

    the person's cornea, particularly in the sub-basal nerve plexus; complete absence of these neurological structures was observed before neurotisation but appeared largely restored 6 months thereafter.

    Case report. Studies with more people and longer follow up included. No new safety outcomes.

    Elbaz U, Bains R, Zuker RM et al. (2014) Restoration of corneal sensation with regional nerve transfers and nerve grafts: a new approach to a difficult problem. JAMA ophthalmology 132(11):1289-95

    n=3 people (4 eyes)

    FU=approx. 6 to 9 months

    Paediatric

    Corneal sensory reconstruction provides corneal sensation in previously anaesthetic corneas. This can be achieved with minimal morbidity using sural nerve grafts, which surgeons commonly use to reconstruct nerve gaps elsewhere. This multidisciplinary approach restores an ocular defence mechanism and may enable subsequent corneal transplant in these people.

    Long-term outcomes of these people are described in Catapano, 2019.

    Fung SSM,

    Catapano J, Elbaz U et al. (2018) In Vivo Confocal Microscopy Reveals Corneal Reinnervation After Treatment of Neurotrophic Keratopathy With Corneal Neurotization. Cornea 37(1):109-12

    n=2

    FU=6 months/2.5 years

    Paediatric

    In both cases, in vivo confocal microscopy showed corneal reinnervation following neurotisation.

    Studies with more people and longer follow up included. No new safety outcomes.

    Kolseth CM, Charlson ES, and Kossler AL. (2020) Corneal Neurotization: A Surgical Treatment for Neurotrophic Keratopathy. Journal of neuro-ophthalmology: the official journal of the North American Neuro-Ophthalmology Society 40(2):e11-2

    n=1

    FU=11 weeks

    In this patient, a return of sensation of 60 mm in all quadrants of the cornea was seen by postoperative Week 11.

    Case report. Studies with more people and longer follow up included. No new safety outcomes.

    Lathrop KL, Duncan K, Yu J et al. (2020) Development of Corneal Sensation With Remodeling of the Epithelium and the Palisades of Vogt After Corneal Neurotization. Cornea 39(5):657-60

    n=1

    FU=2 years

    Paediatric

    The patient tolerated the procedure well and noted subjective improvement in corneal sensation beginning at 16 weeks postoperatively, progressing over the next year. The patient's visual acuity improved to

    20/60 in the left eye with no progression of his corneal scarring 12 months after the procedure.

    Case report. Studies with more people and longer follow up included. No new safety outcomes.

    Peragallo JH, Weil NC and Behshad S. (2021) Conjunctival incision management for strabismus surgery in the post-corneal neurotization patient. Journal of AAPOS 25(1):40-3

    n=2

    FU=approx. 1 year

    Corneal neurotisation was successful in both people with no complications reported. Strabismus surgery was performed at least 6 months after neurotisation for disease stabilisation.

    Studies with more people and longer follow up included. No new safety outcomes.

    Sepehripour S Lloyd MS, Nishikawa H et al. (2017) Surrogate Outcome Measures for Corneal Neurotization in Infants and Children. The Journal of craniofacial surgery 28(5):1167-70

    n=1

    FU=10 months

    Paediatric

    Postoperatively there was evidence of improved corneal

    healing and function after 8 weeks. At 10 months postoperative, the

    cornea was completely free of vascularisation. This is the first time the procedure has been undertaken in a young child.

    Case report. Studies with more people and longer follow up included. No new safety outcomes.

    Steinemann A, Preiser D, Eggenschwiler L et al. (2021) Minimally Invasive Corneal Neurotization for Neurotrophic Keratopathy. Klinische Monatsblatter fur Augenheilkunde 238(4):365-6

    n=1

    FU=1 year

    The results remained stable 1 year after the

    neurotisation, without any signs of corneal

    revascularisation. The patient was extremely pleased with the outcome and his newly improved quality of life.

    Case report. Studies with more people and longer follow up included. No new safety outcomes.

    Thomson DR, Nduka C, Kannan RY et al. (2021) The surgical management of extra-cranial trigeminal nerve palsies: A retrospective case series. Journal of Plastic, Reconstructive and Aesthetic Surgery

    n=11

    FU=10 months

    There was evidence of significant improvement in protective corneal sensation and blinking frequency after corneal neurotisation.

    Identical or very similar patient population to Elalfy (2021) but shorter follow up and fewer reported outcomes.