Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.

Detailed Description
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Patients with progressive keratoconus, pellucid marginal degeneration, 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 assessments.

Official Title
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Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Crosslinking in Eyes With Corneal Ectatic Conditions

Conditions
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Keratoconus, Cornea Ectasia

Intervention / Treatment
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* Combination Product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers Subjects who have one or both eyes that meet criteria 1 and one 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 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 in keratoconus suspect eyes Contact Lens Wearers Only: a. Removal of contact lenses for the required period of time prior to the screening refraction: 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 1 Week, Soft Extended Wear 2 Weeks, Soft Toric 3 Weeks, Rigid Gas Permeable 2 Weeks per decade of wear 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 <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, acanthamoeba, 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: 12 Years
Maximum Age: 60 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: Sequential Assignment
Interventional Model Description: Treatment of patients with disease
Masking: Single


Arms and Interventions

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

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 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 |