Safety and Effectiveness of the PXL-Platinum 330 System

Colorado Eye Consultants

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Ectasia

Treatments: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04401865

PXL-330

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
4. Must be at least 8 years of age.
5. Non-consenting/impaired individuals with a LAR's signature

Exclusion criteria

1. Corneal thickness < 300 microns measured by ultrasound or Pentacam.
2. Contraindications or sensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of Herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Current enrollment in another ophthalmic clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Pulsed, Accelerated

Experimental group

Description:

5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Treatment:

Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Conventional

Active Comparator group

Description:

4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Treatment:

Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution