Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

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Brief Title

Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Official Title

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

Brief Summary

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

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, pachymetry, and visual function.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

K-Max

Secondary Outcome

 Uncorrected Visual Acuity

Condition

Keratoconus

Intervention

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Study Arms / Comparison Groups

 Pulsed 5mW/cm2
Description:  5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

1000

Start Date

February 1, 2021

Completion Date

December 31, 2023

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  8 years of age or older

          -  Signed written informed consent

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

          -  Contact Lens Wearers Only:

          -  Removal of contact lenses (if applicable) for the required period of time prior to the
             screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3
             days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks
             (subjects who cannot function without wearing their contact lenses, may forgo
             discontinuation of contact lenses)

        And one or more of the following:

          -  Presence of central or inferior steepening.

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

          -  Presence of one or more findings associated with keratoconus or pellucid marginal
             degeneration, such as: Fleischer ring, Vogt's striae, Decentered corneal apex,
             Munson's sign, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's
             breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography

          -  Steepest keratometry (Kmax) value ≥ 47.20 D

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

          -  Posterior corneal elevation >16 microns

          -  Thinnest corneal point >300 microns

        Exclusion Criteria:

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

          -  Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.

          -  Previous ocular condition (other than refractive error) in the eye(s) to be treated
             that may predispose the eye for future complications, for example: History of or
             active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent
             erosion syndrome, etc.) 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.

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

          -  A known sensitivity to study medications

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

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

Gender

All

Ages

8 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 12146920146, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04667572

Organization ID

PXL-330-CAT-2


Responsible Party

Sponsor

Study Sponsor

Cornea Associates of Texas


Study Sponsor

, , 


Verification Date

March 2022