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NOT YET RECRUITING
NCT07073729
NA

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

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

Summary

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.

Official title: Corneal Neurotization: A Study on the Outcomes of Nerve Repair for Corneal Sensory Dysfunction

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-08-01

Completion Date

2027-08-01

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

PROCEDURE

Corneal Neurotization

Surgical technique involving the transfer of healthy donor sensory nerves to the anesthetic cornea to restore corneal innervation and sensation in patients with neurotrophic keratitis.

DRUG

Cenergermin

Topical recombinant human nerve growth factor (rhNGF) approved for the treatment of neurotrophic keratitis. Administered as eye drops, it promotes epithelial healing and nerve regeneration.

Locations (1)

Ivey Eye Institute, St. Joseph's Health Care London

London, Ontario, Canada