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RecruitingNCT04094090Updated Oct 20, 2025

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

A Phase 2 interventional study of PXL-330 Platinum device for crosslinking with Peschke riboflavin solution in Keratoconus, Pellucid Marginal Corneal Degeneration and Corneal Ectasia, sponsored by Goodman Eye Center. Recruiting at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Goodman Eye Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2019; still recruiting 7 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study summary

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Read the detailed description

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, pachymetry, and visual function questionnaire.

02

Conditions studied

  • Keratoconus
  • Pellucid Marginal Corneal Degeneration
  • Corneal Ectasia

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03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 500 is above the median of 40 across 205 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

This is the only study on the registry with Goodman Eye Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:

1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:

  1. Fleischer ring
  2. Vogt's striae
  3. Decentered corneal apex
  4. Munson's sign
  5. Apical Corneal scarring consistent with Bowman's breaks
  6. Scissoring of the retinoscopic reflex
  7. Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference > 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation >16 microns 8. Thinnest corneal point >300 microns 9. Contact Lens Wearers Only:

a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft or Scleral 3 days Rigid gas permeable 2 weeks

Exclusion criteria

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this study:

  1. Eyes classified as either normal or atypical normal on the severity grading scheme.
  2. Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.

  3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

    1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
    2. 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.
  4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
  5. A known sensitivity to study medications
  6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
  7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Pulsed, accelerated

    4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

    Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

  • Experimental
    Pusled, accelerated

    8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

    Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Interventions

  • Combination productPXL-330 Platinum device for crosslinking with Peschke riboflavin solution

    Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

    Also known as: Corneal crosslinking

06

What researchers measure

Primary outcomes

  1. Best-contact corrected visual acuity (BSCVA)

    Change in BSCVA compared to baseline.

    Time frame: 3, 6, and 12 months

Secondary outcomes

  1. Uncorrected visual acuity

    Change in UCVA compared to baseline.

    Time frame: 3, 6, and 12 months

  2. Keratometry

    Change in Kmax, compared to baseline.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Goodman Eye Center
    San Francisco, California 94115, United States
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual participant data will be held in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2019 (actual). Primary completion is estimated for Oct 2029, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2019
First posted
Sep 18, 2019
StartActual
Oct 19, 2019
Primary completionEst.
Oct 19, 2029
CompletionEst.
Oct 19, 2029
Last update
Oct 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04094090
Lead sponsor
Goodman Eye Center
Responsible party
Sponsor
First posted
Sep 18, 2019
Start date
Oct 19, 2019
Primary completion
Oct 19, 2029 (estimated)
Completion
Oct 19, 2029 (estimated)
Last update
Oct 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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