Evaluating a new system for treating corneal ectasia

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

This study is testing a new treatment system for people with corneal ectasia and keratoconus to see if it can help improve their eye health and vision.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: Goodman Eye Center (other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04094090 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 10 and older with progressive keratoconus or corneal ectasia.

Not a fit: Patients with stable corneal conditions or those not meeting the specific topographic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients suffering from corneal ectasia.

How similar studies have performed: Other studies have shown promise with corneal cross-linking techniques, but the specific use of the PXL-Platinum 330 system is relatively novel.

Eligibility criteria

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 this trial is running

San Francisco, California

• Goodman Eye Center — San Francisco, California, United States (RECRUITING)

Conditions: Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Ectasia