Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking (NCT03918408) | Clinical Trial Compass
RecruitingPhase 1
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking
United States300 participantsStarted 2019-09-01
Plain-language summary
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
Who can participate
Age range
12 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Scler…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.