Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Completed · Phase 1

Conditions studied: Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration, Corneal Ectasia

In brief

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

Key facts

Study ID

NCT04177082

Run by

Cornea Associates of Texas

People needed

200

Starts

2020-01-10

Expected to finish

2022-05-05

Last updated by the study team

2022-10-19

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:
• 8 years of age or older
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• Contact Lens Wearers Only:
• Removal of contact lenses for the required period of time prior to the screening refraction:
• Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks
• Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
• Fleischer ring
• Vogt's striae
• Decentered corneal apex
• Munson's sign
• Rizzutti's sign
• Apical Corneal scarring consistent with Bowman's breaks
• Scissoring of the retinoscopic reflex
• Crab-claw appearance on topography
• Steepest keratometry (Kmax) value ≥ 47.20 D
• I-S keratometry difference > 1.5 D on the Pentacam/Orbscan map or topography map
• Posterior corneal elevation >16 microns
• Thinnest corneal point >300 microns

Where it is running

• Cornea Associates of Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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