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PXL-Platinum 330 System for Corneal Cross-Linking

This study is testing the PXL-330 Platinum device with Peschke riboflavin solution to see if it's safe and effective for treating conditions like keratoconus (a thinning of the cornea), pellucid marginal degeneration, and infectious keratitis. You might be able to join if you are between 12 and 45 years old and have progressive keratoconus or other corneal thinning conditions. The study will measure changes in your eye's curvature (mean keratometry) after 12 months to see how well the treatment works. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 300 participants. It is testing a combination product: the PXL-330 Platinum device with Peschke riboflavin solution.
What's involved
You would undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system. You would then have monitoring for 1 year, including measurements of your corneal shape, vision, eye pressure, and visual function.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for 1 year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03918408

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

Recruiting
PHASE1Ages 12–45InterventionalTreatment
Pacific Clear Vision Institute
~300 participants
Updated 2024-11-12 on ClinicalTrials.gov
What's tested:PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean keratometry in diopters
Measured over 12 months

Conditions

Keratoconus, Unstable
Bacterial Keratitis
Ectasia of Cornea

Explore related trials

Bacterial keratitisCorneal ectasiaKeratoconus

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • BALAMURALI AMBATI, MD, PhD · PRINCIPAL_INVESTIGATOR · PCVI

Who to contact

BALAMURALI AMBATI, MD, PhD
[email protected]
541-343-5000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Soft Toric: 3 Weeks
Rigid gas permeable: 2 Weeks per decade of wear
Scleral Lenses
Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\]
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion

Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is \<330 microns at the thinnest point in the eye(s) to be treated.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
Patients with active medical implants (e.g. cardiac pacemakers)'
Patients who are aphakic/ pseudophakic

What this trial measures

  • Mean keratometry in diopters12 months

    Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer