Clinical trial NCT04177082: Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratoconus
Pellucid Marginal Corneal Degeneration
Corneal Degeneration
Corneal Ectasia
Lead sponsor: Cornea Associates of Texas
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: K-Max
timeFrame: 12 Months
measure: K-Mean
timeFrame: 12 Months
Secondary outcomes:
measure: Uncorrected Visual Acuity
timeFrame: 12 Months
measure: Best Corrected Visual Acuity
timeFrame: 12 Months
measure: Central Pachymetry
timeFrame: 12 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Cornea Associates of Texas
state: Texas
Study officials:
affiliation: Cornea Associates of Texas
name: Tyrone McCall, MD
role: PRINCIPAL_INVESTIGATOR
References: