NCT05516004 Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning
| NCT ID | NCT05516004 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cohen Laser and Vision Center |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2034-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2024-07-01 with a primary completion date of 2034-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.
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.
Contact & Investigator
Kelly Fitzgerald
STUDY CHAIR
WCG IRB
Frequently Asked Questions
Who can join the NCT05516004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05516004 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05516004 currently recruiting?
Yes, NCT05516004 is actively recruiting participants. Contact the research team at bocalasik@yahoo.com for enrollment information.
Where is the NCT05516004 trial being conducted?
This trial is being conducted at Boca Raton, United States.
Who is sponsoring the NCT05516004 clinical trial?
NCT05516004 is sponsored by Cohen Laser and Vision Center. The principal investigator is Kelly Fitzgerald at WCG IRB. The trial plans to enroll 300 participants.