Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Corneal Neurotization
  • Cenergermin

Treatment groups

10 Participants
are divided into 2 treatment groups