Trial | NCT04177082  Report issue

Title

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
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 Started
Jan 10
2020
Primary Completion
May 05
2022
Study Completion
May 05
2022
Last Update
Oct 19
2022

Combination Product PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

  • Other names: Corneal crosslinking

Pulsed 6mW/cm2 Experimental

6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time

Pulsed 4mW/cm2 Experimental

4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time

Criteria 

Inclusion Criteria

Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:

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 for the required period of time prior to the screening refraction:

Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks

Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
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
No Results Posted