Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

Part of paid clinical trials in Eugene, Oregon.

Sponsor
Pacific Clear Vision Institute
Study ID
NCT03918408
Phase
PHASE1
Status
Recruiting
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Conditions

  • Bacterial Keratitis
  • Ectasia of Cornea
  • Keratoconus, Unstable

Eligibility Criteria

Sex
ALL
Age
12 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Key Dates

Start date
Sep 1, 2019
Status verified
Nov 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed, accelerated
    18 mW, 5 sec, 5 sec off, 10 minutes of illumination
  • Active Comparator: Conventional
    9 mW, continuous 10 minutes of illumination

Primary Outcome Measure

Mean keratometry in diopters [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pacific Clear Vision InstituteEugeneOregon97401
BALAMURALI AMBATI, MD
[email protected]
706-231-3958

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By research site
Pacific Clear Vision Institute· Eugene, OR

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