Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Study Overview
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Brief Summary
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Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes 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, pachymetry, and visual function.

Official Title
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Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution

Conditions
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Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration, Corneal Ectasia

Intervention / Treatment
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* Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin 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 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study: 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 for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses. 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

Ages Eligible for Study
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Minimum Age: 8 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed 6mW/cm2<br>6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution<br>* Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea<br>* Other names: Corneal crosslinking;|
| Experimental: Pulsed 4mW/cm2<br>4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time | Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin 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 |
| --- | --- | --- |
| K-Max | Change in K-Max, compared to baseline | 12 Months | 
| K-Mean | Change in K-Mean, compared to baseline | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity | Change in uncorrected visual acuity, compared to baseline | 12 Months | 
| Best Corrected Visual Acuity | Change in best corrected visual acuity, compared to baseline | 12 Months | 
| Central Pachymetry | Change in central pachymetry, compared to baseline | 12 Months |