Status:
UNKNOWN
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers
Lead Sponsor:
Peschke GmbH
Conditions:
Keratitis
Corneal Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 treatmen...
Detailed Description
This is a prospective, 2-arm parallel-group, single-blind, randomized multicenter study to determine the safety and effectiveness of the PXL Platinum 330 System for performing CXL in eyes with refract...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Central corneal ulcer or hypopyon, and/or failure to improve within 24 hours of initiating conventional antibiotic eyedrops (eg, quinolone, polymyxin/trimethoprim, erythromycin, or other non-fortified antibiotics) or failure to completely re-epithelialisation within 1 week of initiating conventional antibiotic drops
- Consent to a corneal culture for bacterial keratitis (suspected keratitis is 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
- Presence of a perforated corneal ulcer
- Presence of a corneal ulcer that has 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 central corneal ulcer or hypopyon 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 contribute to the corneal condition
- Pregnancy (or plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 24 2024
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT05255016
Start Date
March 14 2022
End Date
February 24 2024
Last Update
October 28 2022
Active Locations (12)
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1
Colorado Eye Consultants
Littleton, Colorado, United States, 80120
2
Gorovoy M.D Eye Specialists
Fort Myers, Florida, United States, 33907
3
Bay Area Eye Institute
Tampa, Florida, United States, 33613
4
Price Vision Group
Indianapolis, Indiana, United States, 46260