OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Evaluation of Changes in Corneal Stromal Thickness Using Anterior Segment OCT Following Treatment of Neurotrophic Ulcers With Oxervate
Sight Medical Doctors PLLC
10 participants
Oct 1, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- Neurotrophic keratitis with stage 3 neurotrophic ulcer (stromal thinning)
- Decreased corneal sensation relative to fellow eye determined qualitatively using wisp of cotton-tipped applicator to compare sensation in each eye without anesthesia.
Exclusion Criteria6
- Impending corneal perforation (descemetocele)
- Unable to physically complete diagnostic testing (cannot position head into slit lamp or OCT)
- Unable to commit to 6 month follow up prior to initiating study
- Unable to self-administer study drug following explanation and demonstration by PI and study coordinator
- Active infectious infiltrate clinically worsening by history or clinical appearance
- Pregnancy; patients must agree to use an acceptable form of birth control during study participation.
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Interventions
Research subjects will use oxervate in affected eye following approved treatment regimen and have their eye measured with optical coherence tomography and a Cochet-Bonnet esthesiometer at various time points before, during and after treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04573647