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

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

Detailed Description
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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.

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

Conditions
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Keratoconus, Unstable, Bacterial Keratitis, Ectasia of Cornea

Intervention / Treatment
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* Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study: 12 years of age or older 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/Galilei/Orbscan/Cassini map or topography map Posterior corneal elevation >16 microns Thinnest corneal point <485 microns Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk). Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of >25% corneal thickness Contact Lens Wearers Only: a. 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 Scleral Lenses 2 Weeks per decade of wear 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): 1. All subjects meeting any of the following criteria will be excluded from this study: Eyes classified as either normal or atypical normal on the severity grading scheme. Corneal pachymetry at the screening exam that is <300 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment of patients with disease
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed, accelerated<br>18 mW, 5 sec, 5 sec off, 10 minutes of illumination | Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution<br>* Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea<br>* Other names: Corneal crosslinking;|
| Active Comparator: Conventional<br>9 mW, continuous 10 minutes of illumination | Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution<br>* Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea<br>* Other names: Corneal crosslinking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean keratometry in diopters | Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale | 1 year |