PXL-Platinum 330 System for Corneal Cross-Linking in Corneal Ectasia

This study is testing the safety and effectiveness of the PXL-Platinum 330 system for treating corneal ectasia (a group of eye conditions where the cornea, the clear front part of your eye, thins and bulges forward). This system uses a combination of Peschke riboflavin solution and UV-A light to strengthen the cornea. You might be able to join if you are 10 years or older and have keratoconus, pellucid marginal degeneration, or post-surgical ectasia. The researchers will measure your best-corrected visual acuity (how well you can see with glasses or contacts) at 3, 6, and 12 months to see if the treatment is successful. The current status of this study is unclear, and it plans to enroll 500 participants.

Study design
This interventional study plans to enroll 500 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system. You will have monitoring visits for 1 year, including measurements of your corneal topography, visual acuity, eye pressure, and corneal thickness.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 year after treatment, with visual acuity measured at 3, 6, and 12 months.

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NCT04094090

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

Recruiting
PHASE2Ages 10+InterventionalTreatment
Goodman Eye Center
~500 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best-contact corrected visual acuity (BSCVA)
Measured over 3, 6, and 12 months
Keratoconus
Pellucid Marginal Corneal Degeneration
Corneal Ectasia
1 sites across 1 states
California1

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  • Best-contact corrected visual acuity (BSCVA)3, 6, and 12 months

    Change in BSCVA compared to baseline.