NCT03918408 Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
| NCT ID | NCT03918408 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pacific Clear Vision Institute |
| Condition | Keratoconus, Unstable |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2029-12 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 300 participants in total. It began in 2019-09-01 with a primary completion date of 2029-12.
⚠ 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 determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
Eligibility Criteria
Inclusion Criteria: Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study. * 12 years of age or older * Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months) * Presence of central or inferior steepening. * Axial topography consistent with keratoconus * Presence of one or more findings associated with keratoconus 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 * I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map * Posterior corneal elevation \>16 microns * Thinnest corneal point \<485 microns * AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk). * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits * For 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 * Scleral Lenses * Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\] * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria (any of the following are reasons for exclusion): * Eyes classified as either normal or atypical normal on the severity grading scheme. * Corneal pachymetry at the screening exam that is \<330 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 nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests. * Patients with active medical implants (e.g. cardiac pacemakers)' * Patients who are aphakic/ pseudophakic
Contact & Investigator
BALAMURALI AMBATI, MD, PhD
PRINCIPAL INVESTIGATOR
PCVI
Frequently Asked Questions
Who can join the NCT03918408 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 45 Years, studying Keratoconus, Unstable. 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 NCT03918408 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03918408 currently recruiting?
Yes, NCT03918408 is actively recruiting participants. Contact the research team at bambati@pcvi.com for enrollment information.
Where is the NCT03918408 trial being conducted?
This trial is being conducted at Eugene, United States.
Who is sponsoring the NCT03918408 clinical trial?
NCT03918408 is sponsored by Pacific Clear Vision Institute. The principal investigator is BALAMURALI AMBATI, MD, PhD at PCVI. The trial plans to enroll 300 participants.