Evaluating the PXL-Platinum 330 System for treating corneal thinning conditions
Official title: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Run by Pacific Clear Vision Institute · NCT03918408 · Data updated 2026-11-12
This study is testing a new device to see if it can safely help people aged 12 and older with corneal thinning conditions like keratoconus and bacterial keratitis improve their vision.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 45 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Pacific Clear Vision Institute Academic / other |
| Locations | 1 site (Eugene, Oregon) |
| Status | Recruiting |
| Started | September 1, 2019 |
| Main results expected | December 2029 |
| Study ends | December 2030 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT03918408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 12 and older with progressive keratoconus or other specified corneal conditions.
✕Probably not a fit
Patients with stable keratoconus or those not meeting the specific inclusion criteria 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 clinical trial aims to assess the safety and effectiveness of the PXL-Platinum 330 system in treating various corneal thinning conditions, including progressive keratoconus and bacterial keratitis. Participants aged 12 and older will undergo epithelial-on corneal cross-linking using the PXL-330 device and Peschke riboflavin solution. The study will monitor patients for one year, measuring corneal topography, visual acuity, intraocular pressure, and visual function through questionnaires to evaluate outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from progressive corneal thinning conditions.
How similar studies have gone: Other studies have shown promise in using corneal cross-linking techniques, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Pacific Clear Vision Institute
Eugene, Oregon, United States Recruiting
Study contacts
- Principal investigator: BALAMURALI AMBATI, MD, PhD — Pcvi
- Study coordinator: BALAMURALI AMBATI, MD, PhD
- Email: bambati@pcvi.com
- Phone: 541-343-5000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intrastromal moxifloxacin added to topical treatment for stubborn bacterial corneal ulcers
This will test whether injecting moxifloxacin into the cornea, alongside standard moxifloxacin eye drops, helps adults whose bacterial keratitis hasn't improved after 48–72 hours of intensive drops.
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Epi-ON corneal crosslinking: 18-minute versus 24-minute UVA exposure for ectatic corneas
This test compares whether an 18-minute or a 24-minute Epi-ON corneal crosslinking procedure better slows progression in people with keratoconus or other ectatic corneal conditions.
-
Rapid assessment of infectious keratitis using cytokines and imaging
This study is testing a new, quick way to diagnose infectious keratitis by looking at tear samples and using advanced imaging to help doctors identify the right treatment faster.
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.