Evaluating a new system for treating corneal ectasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety and effectiveness of the PXL-Platinum 330 system for corneal cross-linking in patients with conditions like keratoconus and corneal ectasia. Participants aged 10 and older will undergo a procedure using the PXL-330 device combined with riboflavin solution, followed by a year of monitoring that includes various eye measurements and visual function assessments. The goal is to determine how well this new approach can stabilize or improve corneal health in affected individuals.

Why it matters

Who can join: the full rules

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:

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. 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.
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.

Where it's running

• Goodman Eye Center
  San Francisco, California, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia

  This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.

  Recruiting Phase 2/3 Price Vision Group · Indianapolis, Indiana · NCT07841470

• Epi-ON corneal crosslinking: 18-minute versus 24-minute UVA exposure for ectatic corneas

  This test compares whether an 18-minute or a 24-minute Epi-ON corneal crosslinking procedure better slows progression in people with keratoconus or other ectatic corneal conditions.

  Recruiting at 12 sites Phase 3 Woolfson Eye Institute · Atlanta, Georgia and 11 other locations · NCT07124910

• Long-term follow-up for patients with corneal diseases

  This study looks at how well different treatments work for people with corneal diseases like keratoconus over the long term, to see how their eyes are doing after surgery.

  Recruiting Technische Universität Dresden · Dresden, Saxony · NCT04251143

• Brillouin hydration mapping to study cornea health

  Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07780890

• Same-day bilateral corneal cross-linking for keratoconus

  This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.

  Recruiting Phase 4 Glaukos Corporation · Westerville, Ohio · NCT07629557

• A Smart Aperture Lens to Help Keratoconus and Presbyopia

  This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.

  Recruiting at 2 sites Azalea Vision · Antwerp and 1 other locations · NCT07559188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.