RecruitingPhase 1NCT03918408

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

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


Sponsor

Pacific Clear Vision Institute

Enrollment

300 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.


Eligibility

Min Age: 12 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial, titled "Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking" (study ID: NCT03918408), is evaluating a specific device used for corneal cross-linking (CXL) — a procedure that strengthens the cornea to slow or stop the progression of keratoconus. Keratoconus is a condition where the cornea gradually thins and bulges into a cone shape, causing distorted vision. The PXL-Platinum 330 system uses UV light and riboflavin eye drops to create new bonds in the corneal tissue, making it stiffer and more stable. The study is open to people aged 12 to 45 who have progressive keratoconus or ectasia (corneal weakening after refractive surgery) with sufficient corneal thickness. Evidence of progression (such as worsening astigmatism or thinning) must be documented. Contact lens wearers must stop wearing them for a specified period before the procedure. You may be eligible if you: - Are between 12 and 45 years old - Have documented progressive keratoconus or post-refractive corneal ectasia - Have a corneal thickness of at least 330 microns at the thinnest point - Have evidence of keratoconus on topography or corneal imaging You may NOT be eligible if you: - Have a cornea thinner than 330 microns at its thinnest point - Are pregnant or planning to become pregnant during the study - Have active corneal disease (e.g., herpes keratitis, recurrent erosion syndrome) - Have a cardiac pacemaker or other active medical implant - Have a known allergy to study medications - Are aphakic (no natural lens) or pseudophakic (artificial lens implant) 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 ribofflavin solution

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea


Locations(1)

Pacific Clear Vision Institute

Eugene, Oregon, United States

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NCT03918408


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