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PXL-Platinum 330 System for Cornea Crosslinking in Keratoconus

This study is looking at how well the PXL Platinum 330 system works to treat keratoconus and other conditions that cause your cornea (the clear front part of your eye) to thin. The system uses a special riboflavin solution and UV light to strengthen your cornea. We are looking for adults aged 18 and older who have healthy eyes but also have signs of cornea thinning, like keratoconus. Success in this study will be measured by how stable your cornea's shape is and changes in a score that measures ectasia (a bulging of the cornea) after one year. The study is currently unclear on its recruitment status.

Study design
This is a single-center study planning to enroll up to 300 participants. It is a prospective, single-arm, non-randomized study.
What's involved
If you qualify, you will have topical anesthetic and then riboflavin eye drops for 25 minutes, followed by 10 minutes of UV light treatment. This procedure is done on an outpatient basis.
Compensation
Not stated in the trial record.
Follow-up
Your cornea's shape and ectasia score will be measured one year after the 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.

NCT05516004

Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning

Recruiting
PHASE2Ages 18+InterventionalTreatment
Cohen Laser and Vision Center
~300 participants
Updated 2024-06-14 on ClinicalTrials.gov
What's tested:PXL Platinum 330 system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stability in maximum and mean keratometric diopters (Kmax)
Measured over one year
+1 more outcome measured

Conditions

Keratoconus

Explore related trials

KeratitisKeratoconusPellucid marginal corneal degenerationPost-surgical ectasia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Kelly Fitzgerald · STUDY_CHAIR · WCG IRB

Who to contact

GREGORY R Cohen, MD
[email protected]
5619818400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

healthy subjects with no other medical or ocular conditions
18 years of age or older
Presence of central or inferior steepening (on Pentacam topograph)
Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details)
Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam
I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
Posterior corneal elevation \>16 microns (µm on Pentacam tomography)
Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography)
Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \>25% corneal thickness
Contact Lens Wearers Only:
Removal of contact lenses for the required period of time prior to the screening refraction:
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion

active infections, collagen vascular disease, allergic to product
Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is \<300 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 cognitive or ambulatory conditions that would prevent eye drop compliance with medications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

What this trial measures

  • Stability in maximum and mean keratometric diopters (Kmax)one year

    As measured by Pentacam tomographer (Oculus)

  • Change in Belin-Ambrosio ectasia scoreone year

    As measured by Pentacam tomographer (Oculus)