Corneal Degeneration, Corneal Ectasia, Keratoconus, Pellucid Marginal Corneal Degeneration
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.
Interventions
COMBINATION_PRODUCTPXL-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
Sponsors
Cornea Associates of Texas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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: 1. 8 years of age or older 2. Signed written informed consent 3. Willingness and ability to comply with schedule for follow-up visits 4. Contact Lens Wearers Only: 1. 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 2. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses. 5. Presence of central or inferior steepening. 6. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 7. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: 1. Fleischer ring 2. Vogt's striae 3. Decentered corneal apex 4. Munson's sign 5. Rizzutti's sign 6. Apical Corneal scarring consistent with Bowman's breaks 7. Scissoring of the retinoscopic reflex 8. Crab-claw appearance on topography 8. Steepest keratometry (Kmax) value ≥ 47.20 D 9. I-S keratometry difference \> 1.5 D on the Pentacam/Orbscan map or topography map 10. Posterior corneal elevation \>16 microns 11. Thinnest corneal point \>300 microns
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K-Max | 12 Months | Change in K-Max, compared to baseline |
| K-Mean | 12 Months | Change in K-Mean, compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity | 12 Months | Change in uncorrected visual acuity, compared to baseline |
| Best Corrected Visual Acuity | 12 Months | Change in best corrected visual acuity, compared to baseline |
| Central Pachymetry | 12 Months | Change in central pachymetry, compared to baseline |
Countries
United States
Outcome results
None listed