Status:
UNKNOWN
Safety and Effectiveness of the PXL-Platinum 330 System
Lead Sponsor:
Colorado Eye Consultants/Cornea Consultants of Colorado
Conditions:
Corneal Ectasia
Keratoconus
Eligibility:
All Genders
8+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04401865
Start Date
June 1 2020
End Date
June 30 2023
Last Update
January 25 2022
Active Locations (3)
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1
Colorado Eye Consultants/Corneal Consultants of Colorado
Littleton, Colorado, United States, 80120
2
Chicago Cornea Consultants, Ltd.
Highland Park, Illinois, United States, 60035
3
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141