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

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ClinicalTrials.gov Identifier: NCT03918408
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pacific Clear Vision Institute

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
Keratoconus, Unstable Bacterial Keratitis Ectasia of Cornea 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment of patients with disease
Masking: None (Open Label)
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2029
Estimated Study Completion Date : June 2030



Intervention Details:
  • 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 Name: Corneal crosslinking


Primary Outcome Measures :
  1. Mean keratometry in diopters [ Time Frame: 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 [ Time Frame: 1 year ]
    Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Fleischer ring
    2. Vogt's striae
    3. Decentered corneal apex
    4. Munson's sign
    5. Rizzutti's sign
    6. Apical Corneal scarring consistent with Bowman's breaks
    7. Scissoring of the retinoscopic reflex
    8. Crab-claw appearance on topography
  7. Steepest keratometry (Kmax) value ≥ 47.20 D
  8. I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
  9. Posterior corneal elevation >16 microns
  10. Thinnest corneal point <485 microns
  11. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
  12. 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
  13. Contact Lens Wearers Only:

    1. 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:

    1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
    2. 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.
  4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
  5. A known sensitivity to study medications
  6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
  7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918408


Contacts
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Contact: BALAMURALI AMBATI, MD, PhD 541-343-5000 bambati@pcvi.com
Contact: Scott Cherne, MD 541-343-5000 scherne@pcvi.com

Sponsors and Collaborators
Pacific Clear Vision Institute
Investigators
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Principal Investigator: BALAMURALI AMBATI, MD, PhD PCVI

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Responsible Party: Pacific Clear Vision Institute
ClinicalTrials.gov Identifier: NCT03918408     History of Changes
Other Study ID Numbers: 1005312
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be help in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:
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Keratoconus
Keratitis
Corneal Diseases
Eye Diseases