Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Position
NCT04213885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-08-29
Summary
To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.
Conditions
- Keratoconus, Unstable
- Ectasia Corneal
- Bacterial Keratitis
Interventions
- COMBINATION_PRODUCT
-
PXL 330 Platinum device/Riboflavin
30mW, 5 sec, 5 sec off, 10 minutes of illumination
Sponsors & Collaborators
-
Eye Specialists of Indiana
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-04
- Primary Completion
- 2024-08-05
- Completion
- 2024-08-05
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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