Actively Recruiting
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
Led by Pacific Clear Vision Institute · Updated on 2024-11-12
300
Participants Needed
1
Research Sites
587 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
CONDITIONS
Official Title
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 12 years of age or older
- Evidence of progressive keratoconus as shown by worsening astigmatism, asymmetry, or vision over the last 3 or more months
- Presence of central or inferior corneal steepening
- Corneal topography consistent with keratoconus
- One or more keratoconus signs such as Fleischer ring, Vogt's striae, decentered corneal apex, Munson's sign, Rizzutti's sign, apical corneal scarring, scissoring retinoscopic reflex, or crab-claw appearance on topography
- Steepest keratometry (Kmax) value of 47.20 diopters or higher
- I-S keratometry difference greater than 1.5 diopters on topography maps
- Posterior corneal elevation over 16 microns
- Thinnest corneal point less than 485 microns
- High genetic keratoconus risk score (67 or higher) on AvaGen testing
- Signed informed consent
- Willingness and ability to attend follow-up visits
- Contact lens wearers must discontinue lenses as specified before screening
You will not qualify if you...
- Eyes classified as normal or atypical normal on severity grading
- Corneal thickness below 330 microns at the thinnest point
- Previous or active corneal diseases aside from refractive error, such as herpes keratitis or recurrent erosion syndrome
- Significant corneal scarring in the treatment zone not related to keratoconus
- Pregnancy or lactation during the study
- Known allergy to study medications
- Nystagmus or inability to maintain steady gaze during treatment or tests
- Active medical implants like pacemakers
- Aphakic or pseudophakic eyes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pacific Clear Vision Institute
Eugene, Oregon, United States, 97401
Actively Recruiting
Research Team
B
BALAMURALI AMBATI, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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