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NCT03918408PHASE1Recruiting

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

Pacific Clear Vision Institute

Start Date

9/1/2019

Completion Date

12/1/2030

Summary

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

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and visual function questionnaire.

Eligibility Criteria

Age Range: 12 years to 45 years

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 * Scleral Lenses * Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\] * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria (any of the following are reasons for exclusion): * Eyes classified as either normal or atypical normal on the severity grading scheme. * Corneal pachymetry at the screening exam that is \<330 microns at the thinnest point in the eye(s) to be treated. * Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: * History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.) * Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure. * Pregnancy (including plan to become pregnant) or lactation during the course of the study * A known sensitivity to study medications * Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests. * Patients with active medical implants (e.g. cardiac pacemakers)' * Patients who are aphakic/ pseudophakic

Interventions

COMBINATION_PRODUCT

PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

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Conditions

Keratoconus, UnstableBacterial KeratitisEctasia of Cornea

Locations

Pacific Clear Vision Institute

Eugene, Oregon 97401

United States