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

Recruiting now · Phase 1

Conditions studied: Keratoconus, Unstable, Bacterial Keratitis, Ectasia of Cornea

In brief

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

Key facts

Study ID

NCT03918408

Run by

Pacific Clear Vision Institute

People needed

300

Starts

2019-09-01

Expected to finish

2030-12-01

Last updated by the study team

2024-11-12

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
• 12 years of age or older
• Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus
• Presence of one or more findings associated with keratoconus such as:
• Fleischer ring
• Vogt's striae
• Decentered corneal apex
• Munson's sign
• Rizzutti's sign
• Apical Corneal scarring consistent with Bowman's breaks
• Scissoring of the retinoscopic reflex
• Crab-claw appearance on topography
• Steepest keratometry (Kmax) value ≥ 47.20 D
• I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
• Posterior corneal elevation >16 microns
• Thinnest corneal point <485 microns
• AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• For Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
• Contact Lens Type Minimum Discontinuation Time:
• Soft: 1 Week
• Soft Extended Wear: 2 Weeks

Where it is running

• Pacific Clear Vision Institute — Eugene, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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