Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers
Brief Summary:
This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of refractory corneal ulcers.
The PXL Platinum 330 System is a combination product consisting of an ultraviolet-A (UV-A) 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke Riboflavin 0.25% Transepithelial Solution) administered in conjunction with the UV-A light as a photosensitizer.
The PXL Platinum 330 System is intended to induce corneal collagen CXL to improve the biomechanical properties of the cornea by strengthening the corneal tissue in the anterior stroma.
Corneal collagen CXL is performed by pretreating the cornea with riboflavin 0.25% ophthalmic solution beginning 40 min before UV-A light exposure to saturate the corneal tissue with the riboflavin photosensitizer.
The cornea is then irradiated with UV-A light (365 nm) at an irradiance of 18 mW/cm2 (5 seconds on, 5 seconds off) for 10 min.
Exposure of the cornea to this UV-A light regimen after topical administration of riboflavin (0.25%) has been shown to induce CXL of the corneal collagen fibrils, with a resultant increase in tensile strength and diameter of the collagen fibrils.
Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the refractive index of the cornea.
Numerous reports and a few clinical trials have also shown benefit in aiding resolution of infective corneal ulcers.