Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution (NCT04667572) | Clinical Trial Compass
CompletedPhase 1
Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
United States249 participantsStarted 2021-02-01
Plain-language summary
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
Who can participate
Age range8 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
And one or more of the following:
* 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
Exclusion Criteria:
* Eyes classified as either normal or atypical normal on the severity grading scheme.
* Corneal thickness \< 300 microns measured by ultrasonic pachymetry or pentacam.
* Previous ocular condition (other than r…