An observational study in Neurotrophic Ulcer, Neurotrophic Keratitis and Neurotrophic Corneal Ulcer, sponsored by Sight Medical Doctors PLLC. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Sight Medical Doctors PLLC · Observational
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.
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 such as previous surgery or infection. In more advanced cases of NK, the cornea can develop an area of thinning called an ulcer. If the cornea becomes too thin, it is at risk for perforation or rupture, which requires extensive surgery to save vision and the eye. This risk can last for many years even after the ulcer is no longer active. 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. The FDA trials demonstrated that Oxervate does lead to more rapid healing of the epithelium (thin surface layer) of the cornea, but it is unclear if it increases the thickness of the stroma, which is the strongest part of the cornea. 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. If treatment with Oxervate increases corneal sensation, then this decreases the risk of future ulcer formation.
About 10 subjects will take part in this research.
Sight Medical Doctors PLLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with stage 3 neurotrophic keratitis (ulcer)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All participants in this trial will be in the treatment group. They will administer Oxervate following the FDA approved guidelines: 1 drop to the affected eye 6 times per day for 8 weeks.
Drug: Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]
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.
Stromal Thickness
To determine with optical coherence tomography if stromal thickness at the thinnest point of a neurotrophic ulcer increases during and after treatment with Oxervate independent of corneal epithelium.
Time frame: 6 Months
Esthesiometry
To quantitatively measure change in corneal esthesiometry during and after treatment of neurotrophic ulcers with Oxervate using Cochet-Bonnet esthesiometry
Time frame: 6 Months
Clinical resolution of epithelial defects
To evaluate time course of clinical resolution of epithelial defects in neurotrophic ulcers subjectively determined by slit lamp examination
Time frame: 6 Months
Plan to share: No
Started Oct 2020 (actual). Primary completion is estimated for Jun 2024, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sight Medical Doctors PLLC