Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
Keratitis, Corneal Ulcer
About this trial
This is an interventional treatment trial for Keratitis
Eligibility Criteria
Inclusion Criteria:
Subjects who have one or both eyes that meet the following criteria will be considered candidates for this study:
- 18 years of age or older
- Ulcers that have not been treated with ophthalmic antibiotic eyedrops (eg, quinolone, polymyxin/trimethoprim, erythromycin, vancomycin, tobramycin, cefazolin, or other ophthalmic antimicrobials) in the preceding 30 days erythromycin, vancomycin, tobramycin, cefazolin, or other ophthalmic antimicrobials) in the preceding 30 days
- Consent to a corneal culture for suspected bacterial keratitis (defined as a corneal epithelial defect of any size with an infiltration of the underlying stroma)
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Minimum corneal thickness >300 μm
Exclusion Criteria:
All subjects meeting any of the following criteria will be excluded from this study:
- Presence of a perforated corneal ulcer
- Presence of a corneal ulcer that had produced a descemetocele
- Presence of a corneal ulcer deeper than 50% depth or 275 μm in the cornea
- Any active ocular infection other than the corneal ulcer to be treated
- Suspicion of amoebic or viral keratitis requiring treatment with topical anti-amoebic or topical antiviral ophthalmic medications
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye(s) for future complications. This may include history of or active corneal disease (eg, herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
- Uncontrolled systemic disease, especially a collagen-vascular or rheumatologic condition that could be contributing to the corneal condition
- Pregnancy (or plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Presence of nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Sites / Locations
- Colorado Eye ConsultantsRecruiting
- Gorovoy M.D Eye SpecialistsRecruiting
- Bay Area Eye InstituteRecruiting
- Price Vision GroupRecruiting
- The cornea & Laser Eye Institute-NJRecruiting
- SightMDRecruiting
- Prisma Health OpthalmologyRecruiting
- Woolfson EyeRecruiting
- Houston Eye AssociatesRecruiting
- San Antonio Eye CenterRecruiting
- Milwaukee Eye SurgeonsRecruiting
- Valley EyeRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Standard of Care Therapy + Sham CXL + Artificial Tears
Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution
Standard-of-care treatment and Sham CXL and administration of artificial tears.
The PXL Platinum 330 Illumination System is a portable electronic medical device. The device's light emitting diode (LED) is used to deliver a metered dose of UV-A light to a targeted treatment area for illuminating the cornea during corneal collagen CXL. PESCHKE-L Solution is a riboflavin 5'-phosphate 0.23% ophthalmic solution that functions as a photosensitizer and is indicated for use with the PXL Platinum 330 Illumination System. Designed to be used when there is epithelial disruption as can occur with a corneal ulcer or wound. It does not contain benzalkonium chloride. It is intended to achieve rapid absorption.