Actively Recruiting
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Led by Goodman Eye Center · Updated on 2025-10-20
500
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
CONDITIONS
Official Title
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 10 years of age or older
- Presence of central or inferior corneal steepening
- Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
- One or more clinical signs of keratoconus or pellucid marginal degeneration such as Fleischer ring, Vogt's striae, decentered corneal apex, Munson's sign, apical corneal scarring, scissoring of retinoscopic reflex, or crab-claw appearance on topography
- Steepest keratometry (Kmax) value of 47.20 diopters or higher
- Inferior-superior keratometry difference greater than 1.5 diopters on Pentacam or topography map
- Posterior corneal elevation greater than 16 microns
- Thinnest corneal point greater than 300 microns
- Contact lens wearers must discontinue lenses for the required period prior to screening: 3 days for soft or scleral lenses, 2 weeks for rigid gas permeable lenses
You will not qualify if you...
- Eyes classified as normal or atypical normal on the severity grading scheme
- Corneal thickness less than 300 microns at the thinnest point at screening
- Previous ocular conditions other than refractive error that may cause complications, including history or active corneal diseases such as herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, or acanthamoeba
- Clinically significant corneal scarring in the treatment zone not related to keratoconus or interfering with the procedure
- Pregnancy or lactation during the study
- Known sensitivity to study medications
- Nystagmus or other conditions preventing steady gaze during treatment or diagnostic tests
- Any current condition that may interfere with or delay epithelial healing as judged by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Goodman Eye Center
San Francisco, California, United States, 94115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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