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

Sponsor
Pacific Clear Vision Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03918408
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
129
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

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

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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 visual function questionnaire.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Treatment of patients with diseaseTreatment of patients with disease
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Randomized at outset
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 :
Sep 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2029
Anticipated Study Completion Date :
Jun 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pulsed, accelerated

30 mW, 5 sec, 5 sec off, 10 minutes of illumination

Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Other Names:
  • Corneal crosslinking

    		•
    Active Comparator: Conventional

    9 mW, continuous 10 minutes of illumination

    Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
    Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
    Other Names:
  • Corneal crosslinking

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean keratometry in diopters [1 year]

      Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer

    Secondary Outcome Measures

    1. Best corrected visual acuity [1 year]

      Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers

    1. 12 years of age or older

    2. Signed written informed consent

    3. Willingness and ability to comply with schedule for follow-up visits

    4. Presence of central or inferior steepening.

    5. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

    6. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:

    7. Fleischer ring

    8. Vogt's striae

    9. Decentered corneal apex

    10. Munson's sign

    11. Rizzutti's sign

    12. Apical Corneal scarring consistent with Bowman's breaks

    13. Scissoring of the retinoscopic reflex

    14. Crab-claw appearance on topography

    15. Steepest keratometry (Kmax) value ≥ 47.20 D

    16. I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map

    17. Posterior corneal elevation >16 microns

    18. Thinnest corneal point <485 microns

    19. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry

    47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes

    1. Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of >25% corneal thickness

    2. Contact Lens Wearers Only:

    3. Removal of contact lenses for the required period of time prior to the screening refraction:

    Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear

    Exclusion Criteria (any of the following are reasons for exclusion):

    1. Eyes classified as either normal or atypical normal on the severity grading scheme.

    2. Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated.

    3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

    4. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)

    5. 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.

    6. Pregnancy (including plan to become pregnant) or lactation during the course of the study

    7. A known sensitivity to study medications

    8. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.

    9. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pacific Clear Vision Institute Eugene Oregon United States 97401

    Sponsors and Collaborators

    • Pacific Clear Vision Institute

    Investigators

    • Principal Investigator: BALAMURALI AMBATI, MD, PhD, PCVI

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Pacific Clear Vision Institute
    ClinicalTrials.gov Identifier:
    NCT03918408
    Other Study ID Numbers:
    • 1005312
    First Posted:
    Apr 17, 2019
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    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
    Additional relevant MeSH terms:
    Keratoconus
    Keratitis

    Study Results

    No Results Posted as of Sep 16, 2021