Safety and Effectiveness of the PXL-Platinum 330 System

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, and pachymetry.

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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Corneal Ectasia, Keratoconus, Pellucid Marginal Corneal Degeneration

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: Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study. Must be at least 8 years of age. Non-consenting/impaired individuals with a LAR's signature Exclusion Criteria: Corneal thickness < 300 microns measured by ultrasound or Pentacam. Contraindications or sensitivities to any study medications or their components. Pregnancy or breastfeeding. Any history of Herpes simplex corneal disease in an eye to be treated. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. Inability to cooperate with diagnostic tests. Current enrollment in another ophthalmic clinical trial.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed, Accelerated<br>5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: 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 cross-linking;|
| Active Comparator: Conventional<br>4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: 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 cross-linking;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected distance visual acuity | Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline. | 6 months | 

Secondary Outcome Measures

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