Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. Our study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Insulin

Criteria

Inclusion Criteria:

• Diagnosis of neurotrophic keratitis with persistent epithelial defect that has been refractory to conventional treatments for at least 2 weeks

• 18 years or older

• Able to provide informed consent

• Failed other conventional treatments for neurotrophic keratitis

• Understanding and accepting of use of topical insulin alone

Exclusion Criteria:

• Less than 18 years old

• Pregnant or breastfeeding women

• Unable to provide informed consent

• Unable to comply with tests/follow-up

• Lid function abnormalities (e.g., lagophthalmos, entropion, ectropion, or abnormal orbicularis function from cranial nerve 7 palsy or Bell's palsy)

• Patients who require ongoing topical treatment (e.g. topical ganciclovir)