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

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

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, pachymetry, and visual function questionnaire.

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

Conditions
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Keratoconus, Pellucid Marginal 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 and 1 or more of the following criteria will be considered candidates for this study: 1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. 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 Apical Corneal scarring consistent with Bowman's breaks Scissoring of the retinoscopic reflex Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference > 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation >16 microns 8. Thinnest corneal point >300 microns 9. 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 or Scleral 3 days Rigid gas permeable 2 weeks Exclusion Criteria: 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

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: Single Group Assignment
Interventional Model Description: The study is a prospective, double-armed, randomized, single study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed, accelerated<br>4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution | 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: Pusled, accelerated<br>8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution | 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 |
| --- | --- | --- |
| Best-contact corrected visual acuity (BSCVA) | Change in BSCVA compared to baseline. | 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected visual acuity | Change in UCVA compared to baseline. | 3, 6, and 12 months | 
| Keratometry | Change in Kmax, compared to baseline. | 1 year |