Corneal Nerve Regeneration Study
Corneal Nerve Regeneration in Neurotrophic/Anesthetic Corneas After Using a Temporary, Sutureless Amniotic Membrane Graft (ProKera)
Protocol ID
Protocol Description
One method of treating non-healing epithelial defects in neurotrophic (anesthetic) corneas is to suture (sew) amniotic membranes onto the cornea. The amniotic membrane (AM) is the membrane that surrounds the developing fetus inside the uterus. When appropriately obtained, processed, and preserved, AM has been successfully used as a nutrient replacement source for the surface of the eye and is effective in treating severe and progressive corneal surface disorders such as neurotrophic ulcers. The sewing in of amniotic membranes has historically required taking patients to the operating room. The purpose of this study is to determine if the use of ProKera, a special contact lens-like device containing an amniotic membrane will help to heal and re-grow vital nerves in corneas without the need for sutures or visits to the operating room. ProKera uses amniotic membranes recovered under sterile conditions from donors who passed infection disease testing. Corneal nerve re-growth will be assessed using a Confocal microscope. Confocal microscopy is an approved, relatively new device that has been established as an effective way of looking at corneal structures including corneal nerves in living people. This technology has been used to look at corneal nerves after refractive surgery procedures such as LASIK and to help in diagnosis of severe corneal infections. We propose to use this safe, non-invasive technology to look at the extent of corneal nerve re-growth in your cornea after application of ProKera.
ProKera is intended for use in eyes in which ocular surface cells have been damaged, or underlying stroma is inflamed or scarred. It has been approved by the US FDA as a Class II medical device.
Eligibility Criteria
Patients with Neurotrophic (anesthetic) cornea and persistent epithelial abrasion or keratopathy (surface irritation) that has been resistant to standard treatment regimens
Primary Investigator(s)
- Ira Udell, MD