Evaluating a new system for cornea crosslinking in patients with cornea thinning

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

This study is testing a new system for treating cornea thinning in people with keratoconus to see if it is safe and effective.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cohen Laser and Vision Center (Academic / other)
• Locations: 1 site (Boca Raton, Florida)
• Trial ID: NCT05516004 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the PXL Platinum 330 system for cornea crosslinking in patients with keratoconus and other cornea thinning conditions. Conducted over 10 years, it will enroll up to 300 patients in a single-center, nonrandomized design. Participants will undergo a series of evaluations and treatments involving riboflavin application and UVA light exposure. The study will monitor outcomes at multiple time points post-treatment to determine the system's efficacy.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older with specific topographic and clinical findings consistent with keratoconus or related conditions.

Not a fit: Patients with other significant ocular or medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with keratoconus and cornea thinning conditions.

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

Eligibility criteria

Inclusion Criteria:

* healthy subjects with no other medical or ocular conditions

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:

* 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:

Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear

* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* active infections, collagen vascular disease, allergic to product

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.
* 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.

Where this trial is running

Boca Raton, Florida

• Cohen Laser and Vision Center — Boca Raton, Florida, United States (Recruiting)

Study contacts

• Study coordinator: GREGORY R Cohen, MD

Conditions Keratoconus