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Safety and Effectiveness of the PXL-Platinum 330 System

Sponsor
Colorado Eye Consultants/Cornea Consultants of Colorado (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04401865
Collaborator
(none)
300
Enrollment
3
Locations
2
Arms
36.9
Anticipated Duration (Months)
100
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
 Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pulsed, Accelerated

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
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Other Names:
  • Corneal cross-linking

    		•
    Active Comparator: Conventional

    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
    Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
    Other Names:
  • Corneal cross-linking

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corrected distance visual acuity [6 months]

      Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.

    Secondary Outcome Measures

    1. Uncorrected visual acuity [6 months]

      Change in UCVA at 6 months, compared to baseline.

    2. Keratometry [12 months]

      Change in Kmax, compared to baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colorado Eye Consultants/Corneal Consultants of Colorado Littleton Colorado United States 80120
    2 Chicago Cornea Consultants, Ltd. Highland Park Illinois United States 60035
    3 Cleveland Eye Clinic Brecksville Ohio United States 44141

    Sponsors and Collaborators

    • Colorado Eye Consultants/Cornea Consultants of Colorado

    Investigators

    • Principal Investigator: S. Lance Forstot, M.D., Colorado Eye Consultants/Corneal Consultants of Colorado

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Colorado Eye Consultants/Cornea Consultants of Colorado
    ClinicalTrials.gov Identifier:
    NCT04401865
    Other Study ID Numbers:
    • PXL-330
    First Posted:
    May 26, 2020
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Keratoconus
    Riboflavin

    Study Results

    No Results Posted as of Jan 25, 2022