Evaluating a new system for cornea crosslinking in patients with cornea thinning
Official title: Safety and Effectiveness of the PXL -Platinum 330 System for Cornea Collagen Crosslinking in Eyes With Corneal Thinning Conditions
Run by Cohen Laser and Vision Center · NCT05516004 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Cohen Laser and Vision Center Academic / other |
| Locations | 1 site (Boca Raton, Florida) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | June 1, 2034 |
| Study ends | June 1, 2034 |
| Registry record updated | June 14, 2024 |
| Trial ID | NCT05516004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18 and older with specific topographic and clinical findings consistent with keratoconus or related conditions.
✕Probably not a fit
Patients with other significant ocular or medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with cornea crosslinking techniques, but the specific use of the PXL Platinum 330 system is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Cohen Laser and Vision Center
Boca Raton, Florida, United States Recruiting
Study contacts
- Study coordinator: GREGORY R Cohen, MD
- Email: bocalasik@yahoo.com
- Phone: 5619818400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
-
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.
-
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.
-
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.
-
GLK-221 eye drops for keratoconus
This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.
-
Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus
This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.