Safety and Effectiveness of the PXL-Platinum 330 System
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Corneal Ectasia, Keratoconus, Pellucid Marginal Corneal Degeneration
In brief
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Key facts
- Study ID
- NCT04401865
- Run by
- Colorado Eye Consultants/Cornea Consultants of Colorado
- People needed
- 300
- Starts
- 2020-06-01
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2022-01-25
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
- Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
- Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
- Must be at least 8 years of age.
- Non-consenting/impaired individuals with a LAR's signature
You may not qualify if…
- Corneal thickness < 300 microns measured by ultrasound or Pentacam.
- Contraindications or sensitivities to any study medications or their components.
- Pregnancy or breastfeeding.
- Any history of Herpes simplex corneal disease in an eye to be treated.
- Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
- Inability to cooperate with diagnostic tests.
- Current enrollment in another ophthalmic clinical trial.
Where it is running
- Colorado Eye Consultants/Corneal Consultants of Colorado — Littleton, Colorado, United States (enrolling)
- Cleveland Eye Clinic — Brecksville, Ohio, United States (enrolling)
- Chicago Cornea Consultants, Ltd. — Highland Park, Illinois, United States
Full record on ClinicalTrials.gov
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