Evaluating the PXL-Platinum 330 System for treating corneal thinning conditions
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
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 |
| Enrollment | 300 (estimated) |
| Ages | 12 Years to 45 Years |
| Sex | All |
| Sponsor | Pacific Clear Vision Institute Academic / other |
| Locations | 1 site (Eugene, Oregon) |
| Trial ID | NCT03918408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older with progressive keratoconus or other specified corneal conditions.
Not a fit: Patients with stable keratoconus or those not meeting the specific inclusion criteria may not benefit from this study.
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 performed: Other studies have shown promise in using corneal cross-linking techniques, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Eugene, Oregon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.