Protocol for the Corneal Neurotization Assessment Registry: An Observational Study in Patients with Neurotrophic Keratopathy Treated with Corneal Neurotization

BackgroundNeurotrophic keratopathy (NK) is a rare degenerative corneal disease caused by impaired trigeminal innervation, resulting in reduced corneal sensation, impaired epithelial healing, ulceration, and risk of perforation or vision loss. Corneal innervation is essential for protective reflexes, epithelial maintenance, and ocular surface homeostasis. Conventional medical therapies may promote epithelial healing but do not directly restore corneal innervation. Corneal neurotization (CN) has emerged as a surgical strategy in which healthy donor sensory axons are transferred to denervated corneas to provide innervation. Multiple procedural variations now exist, including differences in donor nerve selection, graft use, and methods of limbal nerve insertion. A broad variety of NK etiologies is also being treated, including congenital, infectious, tumor, or other causes. However, published evidence remains limited by small case series, heterogeneous surgical methods, short follow-up periods, and inconsistent outcome reporting. ObjectiveTo address the need for standardized long-term outcome data in CN, we established the Corneal Neurotization Assessment (CorNeA) Registry, an international multicenter observational registry designed to evaluate patients undergoing CN. MethodsThe CorNeA Registry captures demographic characteristics, disease etiology, surgical technique, and longitudinal ocular outcomes in patients with NK treated with CN. Data are recorded in REDCap and include both retrospective and prospective patient enrollment across participating centers. Patients are followed longitudinally after surgery without a predefined endpoint to permit long-term assessment of corneal sensation recovery, ulcer recurrence, and visual outcomes. At the time of reporting, the registry includes 58 patients from multiple international centers, with active expansion ongoing. ConclusionBecause NK is rare and CN remains an evolving surgical field, long-term comparative data are lacking. The CorNeA Registry provides the first international platform to characterize patient selection, procedural variation, and long-term outcomes after CN, with the goal of informing future surgical decision-making and outcome standardization.