CompletedPhase 1

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

United States200 participantsStarted 2020-01-10

Plain-language summary

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Who can participate

Age range

8 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

. 8 years of age or older
. Signed written informed consent
. Willingness and ability to comply with schedule for follow-up visits
. Contact Lens Wearers Only:
. Removal of contact lenses for the required period of time prior to the screening refraction:
. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
. Presence of central or inferior steepening.
. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

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.

What they're measuring

K-Max

Timeframe: 12 Months

K-Mean

Timeframe: 12 Months

Trial details

NCT IDNCT04177082

SponsorCornea Associates of Texas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-05

View on ClinicalTrials.gov More Keratoconus trials