Status:
COMPLETED
Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Lead Sponsor:
Cornea Associates of Texas
Conditions:
Keratoconus
Pellucid Marginal Corneal Degeneration
Eligibility:
All Genders
8+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT04667572
Start Date
February 1 2021
End Date
August 21 2024
Last Update
February 11 2025
Active Locations (1)
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1
Cornea Associates of Texas
Dallas, Texas, United States, 75231