Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

Part of paid clinical trials in San Francisco, California.

Sponsor
Goodman Eye Center
Study ID
NCT04094090
Phase
PHASE2
Status
Recruiting
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Conditions

  • Corneal Ectasia
  • Keratoconus
  • Pellucid Marginal Corneal Degeneration

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PXL-330 Platinum device for crosslinking with Peschke riboflavin solution — COMBINATION_PRODUCT
    Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Study Details

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 Dates

Start date
Oct 19, 2019
Status verified
Oct 2025
Primary completion
Oct 19, 2029
Completion
Oct 19, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed, accelerated
    4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
  • Experimental: Pusled, accelerated
    8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Primary Outcome Measure

Best-contact corrected visual acuity (BSCVA) [ Time Frame: 3, 6, and 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Goodman Eye CenterSan FranciscoCalifornia94115
Daniel F Goodman, MD
[email protected]
4154743333
Daniel F Goodman, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Goodman Eye Center· San Francisco, CA

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