RecruitingPhase 2NCT04094090
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Sponsor
Goodman Eye Center
Enrollment
500 participants
Start Date
Oct 19, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Eligibility
Min Age: 10 Years
Plain Language Summary
Simplified for easier understanding
This study evaluates a new ultraviolet (UV) light system called PXL-Platinum 330 for corneal cross-linking — a procedure that strengthens the cornea to slow or stop the progression of keratoconus or other corneal thinning conditions.
You may be eligible if:
- You are 10 years old or older
- You have keratoconus, post-surgical ectasia, or pellucid marginal degeneration confirmed by eye examination and imaging
- Your cornea's thinnest point is at least 300 microns
You may NOT be eligible if:
- Your cornea is classified as normal on testing
- Your cornea is thinner than 300 microns at the thinnest point
- You have active corneal disease (e.g., herpes simplex, recurrent corneal erosion)
- You are pregnant, planning pregnancy, or breastfeeding
- You have a known allergy to study eye drops
- You have a condition that prevents you from holding a steady gaze
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
COMBINATION_PRODUCTPXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04094090
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