Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers
Public ClinicalTrials.gov record NCT05255016. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of refractory corneal ulcers. The PXL Platinum 330 System is a combination product consisting of an ultraviolet-A (UV-A) 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke Riboflavin 0.25% Transepithelial Solution) administered in conjunction with the UV-A light as a photosensitizer. The PXL Platinum 330 System is intended to induce corneal collagen CXL to improve the biomechanical properties of the cornea by strengthening the corneal tissue in the anterior stroma. Corneal collagen CXL is performed by pretreating the cornea with riboflavin 0.25% ophthalmic solution beginning 40 min before UV-A light exposure to saturate the corneal tissue with the riboflavin photosensitizer. The cornea is then irradiated with UV-A light (365 nm) at an irradiance of 18 mW/cm2 (5 seconds on, 5 seconds off) for 10 min. Exposure of the cornea to this UV-A light regimen after topical administration of riboflavin (0.25%) has been shown to induce CXL of the corneal collagen fibrils, with a resultant increase in tensile strength and diameter of the collagen fibrils. Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the refractive index of the cornea. Numerous reports and a few clinical trials have also shown benefit in aiding resolution of infective corneal ulcers.
Study identification
- NCT ID
- NCT05255016
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 488 participants
Conditions and interventions
Conditions
Interventions
- PXL Platinum 330 system + Riboflavin 0.25% TE Solution Combination Product
- Sham CXL + Artificial Tears Other
Combination Product · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2022
- Primary completion
- Nov 23, 2023
- Completion
- Feb 23, 2024
- Last update posted
- Oct 27, 2022
2022 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Colorado Eye Consultants | Littleton | Colorado | 80120 | Recruiting |
| Gorovoy M.D Eye Specialists | Fort Myers | Florida | 33907 | Recruiting |
| Bay Area Eye Institute | Tampa | Florida | 33613 | Recruiting |
| Price Vision Group | Indianapolis | Indiana | 46260 | Recruiting |
| The cornea & Laser Eye Institute-NJ | Teaneck | New Jersey | 07666 | Recruiting |
| SightMD | Babylon | New York | 11702 | Recruiting |
| Prisma Health Opthalmology | Columbia | South Carolina | 29203 | Recruiting |
| Woolfson Eye | Chattanooga | Tennessee | 37421 | Recruiting |
| Houston Eye Associates | Houston | Texas | 77008 | Recruiting |
| San Antonio Eye Center | Lackland Air Force Base | Texas | 78236 | Recruiting |
| Milwaukee Eye Surgeons | Milwaukee | Wisconsin | 53203 | Recruiting |
| Valley Eye | Oshkosh | Wisconsin | 54901 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05255016, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2022 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05255016 live on ClinicalTrials.gov.