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Taking people in United StatesPhase 2

Corneal cross-linking device for keratoconus and other corneal bulging conditions

Tests a cross-linking device with riboflavin in people with keratoconus or corneal ectasia.

Key facts

Who runs it
Goodman Eye Center
Where
San Francisco, United StatesSee the site
Trial code
Registry title
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Status
Recruiting
Phase
Phase 2
People taking part
500 people, planned
Started
19 Oct 2019
Expected to end
19 Oct 2029
Type of study
Interventional, 2 groups
Treatments tested
  • PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Record updated
20 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 10 years or older with corneal ectasia, a thinning and bulging of the clear front of the eye. This includes keratoconus, ectasia after eye surgery, or pellucid marginal degeneration. The trial tests corneal cross-linking with the PXL-330 Platinum device and Peschke riboflavin solution.

Age
10 years or older
Sex
All sexes
Disease stage
At least one eye with keratoconus, post-surgical ectasia or pellucid marginal degeneration. Signs can include steepening of the cornea, Kmax ≥ 47.20 D, I-S keratometry difference > 1.5 D, posterior corneal elevation >16 microns. The thinnest point of the cornea must be >300 microns.
Earlier treatment
Contact lens wearers must stop wearing them before the screening eye test: soft or scleral lenses for 3 days, rigid gas permeable lenses for 2 weeks.

Main reasons for not taking part

  • Eyes graded as normal or atypical normal
  • Cornea thinner than 300 microns at its thinnest point in the eye to be treated
  • Past or current corneal disease, such as herpes infection, or corneal scarring not caused by keratoconus that would get in the way of treatment
  • Pregnancy, plans to become pregnant, or breastfeeding during the study
  • Known sensitivity to the study medicines, nystagmus (eye shaking) or a condition that slows healing of the eye surface

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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:
  • Fleischer ring
  • Vogt's striae
  • Decentered corneal apex
  • Munson's sign
  • Apical Corneal scarring consistent with Bowman's breaks
  • Scissoring of the retinoscopic reflex
  • 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:
  • 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

Who cannot take part

  • 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
  • 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
  • All subjects meeting any of the following criteria will be excluded from this study:
  • 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
  • Pregnancy (including plan to become pregnant) or lactation during the course of the study

Where in United States

  • Goodman Eye CenterSan Francisco, United StatesContact: Daniel F Goodman, MDTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Pulsed, acceleratedTreatment being tested

    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

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

  • Pusled, acceleratedTreatment being tested

    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

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Plain-language title
Corneal cross-linking device for keratoconus and other corneal bulging conditionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
20 October 2025