Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking (NCT03918408) | Clinical Trial Compass
RecruitingPhase 1
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
United States300 participantsStarted 2019-09-01
Plain-language summary
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
Who can participate
Age range12 Years – 45 Years
SexALL
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Inclusion Criteria:
Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
* 12 years of age or older
* Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
* Presence of central or inferior steepening.
* Axial topography consistent with keratoconus
* Presence of one or more findings associated with keratoconus 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/Galilei/Orbscan/Cassini map or topography map
* Posterior corneal elevation \>16 microns
* Thinnest corneal point \<485 microns
* AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits
* For 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: 1 Week
* Soft Extended Wear: 2 Weeks
* Soft Toric: 3 Weeks
* Rigid gas permeable: 2 Weeks per decade of wear
* Scler…