NCT04094090 Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
| NCT ID | NCT04094090 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Goodman Eye Center |
| Condition | Keratoconus |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2019-10-19 |
| Primary Completion | 2029-10-19 |
Eligibility & Interventions
Eligibility Fast-Check
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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 500 participants in total. It began in 2019-10-19 with a primary completion date of 2029-10-19.
⚠ 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
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
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.
Frequently Asked Questions
Who can join the NCT04094090 clinical trial?
This trial is open to participants of all sexes, aged 10 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 NCT04094090 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 NCT04094090 currently recruiting?
Yes, NCT04094090 is actively recruiting participants. Visit ClinicalTrials.gov or contact Goodman Eye Center to inquire about joining.
Where is the NCT04094090 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04094090 clinical trial?
NCT04094090 is sponsored by Goodman Eye Center. The trial plans to enroll 500 participants.