Status:
UNKNOWN
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated 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-masked, randomized multicenter study to determine the safety and effectiveness of the PXL Platinum 330 System for performing CXL in eyes with previo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 24 2024
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT05255107
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