Trial | NCT04213885  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    300
To determine whether the Peschke PXL-330 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
May 04
2020
Primary Completion
Sep 01
2029
Anticipated
Study Completion
Sep 01
2030
Anticipated
Last Update
Feb 15
2023

Combination Product PXL 330 Platinum device/Riboflavin

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

Pulsed Accelerated Experimental

30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

Conventional Active Comparator

9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

Criteria 

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

Fleisher 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 greater than or equal to 47.2
I-S keratometry difference < 1.5 D on the Pentacam 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, or patients undergoing PRK/SMILE in keratoconus suspect eyes
Bacterial or fungal 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 require period of time prior to the screening refraction:

Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear -

Exclusion Criteria:

Eyes classified as normal or atypical normal on the severity grading scheme
Corneal pachymetry at the screening exam that is <300 microns at the 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, acanthamoeba, etc.)
Clinically significant corneal scarring 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 the study medications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.

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

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No Results Posted