Official Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    300
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
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 Started
Sep 01
2019
Primary Completion
Jun 30
2029
Anticipated
Study Completion
Jun 30
2030
Anticipated
Last Update
Sep 16
2021

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

Pulsed, accelerated Experimental

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

Conventional Active Comparator

9 mW, continuous 10 minutes of illumination

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

12 years of age or older
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits
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/Galilei/Orbscan/Cassini map or topography map
Posterior corneal elevation >16 microns
Thinnest corneal point <485 microns
Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
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

Contact Lens Wearers Only:

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):

Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated.

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, acanthomeoeba, 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.
No Results Posted