This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal neurotization surgery and topical Cenergermin (Oxervate). Participants will receive treatment based on clinical decision-making, not randomization, and will be followed for 12 months through eight visits at the Ivey Eye Institute, St. Joseph's Health Care London. Data collected during routine eye examinations and validated quality-of-life questionnaires will be used to assess visual outcomes, corneal structure and function, and patient-reported well-being. This feasibility study is funded by the Lawson Research Institute Internal Research Fund and is intended to generate preliminary evidence for a future randomized trial.
Adults aged 19 years and older.
Diagnosis of neurotrophic keratitis with reduced or absent corneal sensation.
Clinical indication for either corneal neurotization surgery or topical Cenergermin treatment, as determined by the treating ophthalmologist.
Ability to provide informed consent.
Active ocular infection or inflammation.
Previous corneal neurotization procedure in the affected eye.
Contraindications to general anesthesia or surgical intervention.
Participation in another interventional clinical trial within the past 3 months.
Parallel
Corneal Neurotization
Procedure/SurgerySurgical technique involving the transfer of healthy donor sensory nerves to the anesthetic cornea to restore corneal innervation and sensation in patients with neurotrophic keratitis.
Cenergermin
DrugTopical recombinant human nerve growth factor (rhNGF) approved for the treatment of neurotrophic keratitis. Administered as eye drops, it promotes epithelial healing and nerve regeneration.
Change in Corneal Sensitivity
Measured using Cochet-Bonnet esthesiometry to evaluate restoration of corneal sensation following intervention.
Change in best-corrected visual acuity
Best-corrected visual acuity will be assessed using a standardized Snellen chart or equivalent method. The goal is to evaluate visual improvement following corneal neurotization or cenergermin treatment.
Overall Impact of the Procedure
Comprehensive assessment of the overall effects of corneal neurotization, including clinical and functional outcomes as well as patient-reported measures of ocular comfort, perceived visual function, and general well-being at 12 months post-procedure.
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