Trials / Unknown
UnknownNCT04401865
Safety and Effectiveness of the PXL-Platinum 330 System
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Colorado Eye Consultants/Cornea Consultants of Colorado · Industry
- Sex
- All
- Age
- 8 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
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, intraocular pressure, and pachymetry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2022-06-30
- Completion
- 2023-06-30
- First posted
- 2020-05-26
- Last updated
- 2022-01-25
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04401865. Inclusion in this directory is not an endorsement.