Safety and Effectiveness of the PXL-Platinum 330 System
NCT ID: NCT04401865
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
300 participants
INTERVENTIONAL
2020-06-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pulsed, Accelerated
5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
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
Conventional
4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
4. Must be at least 8 years of age.
5. Non-consenting/impaired individuals with a LAR's signature
Exclusion Criteria
2. Contraindications or sensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of Herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Current enrollment in another ophthalmic clinical trial.
8 Years
ALL
No
Sponsors
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Colorado Eye Consultants/Cornea Consultants of Colorado
INDUSTRY
Responsible Party
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Principal Investigators
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S. Lance Forstot, M.D.
Role: PRINCIPAL_INVESTIGATOR
Colorado Eye Consultants/Corneal Consultants of Colorado
Locations
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Colorado Eye Consultants/Corneal Consultants of Colorado
Littleton, Colorado, United States
Chicago Cornea Consultants, Ltd.
Highland Park, Illinois, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PXL-330
Identifier Type: -
Identifier Source: org_study_id
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