4 Clinical Trials for Various Conditions
Neurotrophic keratitis (NK) is a condition where the cornea, or clear outer covering of the eye, has reduced sensation due to a variety of reasons. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. The purpose of this research is to find out if Oxervate (cenegermin-bkbj 0.002%) an FDA-approved treatment for neurotrophic corneal ulcers leads to an increase in thickness of the corneal stroma (middle layer of the cornea) during and after treatment of a neurotrophic ulcer. Corneal thickness will be measured using optical coherence tomography (OCT), a non-contact imaging device used routinely in ophthalmology examinations. Corneal sensation will also be measured during and after treatment with a device called a Cochet-Bonnet esthesiometer to see if the treatment increases corneal sensation.
The purpose of this study is to assess the efficacy of sural nerve transfer and cadaveric nerve graft to re-establish corneal sensation in patients with neurotrophic keratopathy.
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a demyelinating chronic progressive or relapsing neuropathy believed to be secondary to an autoimmune response against peripheral nerve antigens.5 We have observed two patients with CIDP with decreased corneal sensation who also suffered neurotrophic corneal ulcers and severe visual loss in the affected eyes. We want to explore the relationship of CIDP and corneal sensitivity. Our hypothesis is that people with CIDP have decreased corneal sensation compared to those without. We plan to perform a prospective study measuring corneal sensation in patients (proposed n=10) with CIDP and without to determine (1) if a difference exists in patients with CIDP compared to controls and (2) the magnitude of the difference. If a difference is detected in corneal sensitivity in patients with CIDP, this awareness amongst physicians and patients may help prevent blinding complications.
Primary Objective: To assess the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on overall corneal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16. Secondary Objectives: To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16. To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal reflectivity via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16. To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal sensitivity via Cochet-Bonnet aesthesiometer in the center of the lesion with respect to change from baseline at weeks 4, 8, and 16.