Protocol outlines corneal neurotization for neurotrophic keratopathy with noted observational limitations

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medRxiv Published April 29, 2026 Medically reviewed April 29, 2026 Study authors: Sharma, P.; Wali, K.; Crabtree, J.; Stevens, K.; Tran, K.; Li, J.; Williams, S.; Boente, C. S.; Fein… DOI ↗ By Dr. Lars van Dijk, PhD · Surgical, Procedural & Diagnostic

Key Takeaway

Note that corneal neurotization protocols for neurotrophic keratopathy have significant observational limitations.

This document serves as a protocol for an observational study involving patients with neurotrophic keratopathy treated with corneal neurotization. The research is conducted within a multicenter database involving a global collaboration. Because this is a protocol, primary outcomes regarding long-term ocular outcome data and secondary outcomes such as patient demographic characteristics and surgical approach variations are not yet available. Safety data, including adverse events and tolerability, are not reported in this protocol. The study phase is not reported. The authors explicitly note several limitations that affect the current evidence base. These include small sample sizes, varied published surgical methods, short follow-up periods, and a lack of standardized outcomes or comparative analyses. Funding or conflicts of interest are not reported. Causality and certainty notes are not reported. The follow-up is described as postoperatively with no specified data collection endpoint. Consequently, definitive conclusions on efficacy or safety cannot be drawn from this source alone.

Study Details

EvidenceLevel 5

PublishedApr 2026

View Original Abstract ↓

Background: Neurotrophic keratopathy (NK) is a rare condition in which innervation to the cornea is diminished or lost entirely, causing deficits in corneal sensation and trophic mechanisms. Corneal innervation is vital for protective eye reflexes and corneal healing. Traditional, non-surgical treatments do not address the underlying lack of innervation, and patients with NK remain at risk for developing degenerative ulcerative disease, perforation, and vision loss. During corneal neurotization (CN,) surgeons transfer healthy donor nerve fibers to denervated corneas. Many procedural variations exist, including in donor nerve and graft selection. Research on CN is currently limited by small sample sizes, varied published surgical methods, short follow-up periods, and a lack of standardized outcomes or comparative analyses. Objective: We aim to address the need for long-term ocular outcome data in CN surgery by establishing the Corneal Neurotization Assessment (CorNeA) Registry, an observational, multicenter database, in a global collaboration of leaders in CN. Methods: The CorNeA Registry is a data collection tool designed to study clinical outcomes in NK patients who undergo CN. Data including patient demographic characteristics, surgical approach variations, and ocular outcomes are recorded in REDCap. Data are collected prospectively for patients undergoing surgery and retrospectively in patients who have already undergone CN. Patients are followed postoperatively with no specified data collection endpoint. Conclusion: Due to the rarity of NK and recent development of CN, there is no database to track long-term CN outcomes in NK patients. The CorNeA Registry will be used to better understand NK patient outcomes and identify factors that affect CN results.