Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Cornea Associates of Texas

Status and phase: Completed; Phase 1

Conditions: Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Ectasia; Corneal Degeneration

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04177082

PXL-330-CAT

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pulsed 6mW/cm2

Experimental group

Description:

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

Treatment:

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

Pulsed 4mW/cm2

Experimental group

Description:

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

Treatment:

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