Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning

Q: Who can participate in NCT05516004?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05516004?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning (NCT05516004) is a Phase 2 interventional studying Keratoconus, sponsored by Cohen Laser and Vision Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Keratoconus and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - healthy subjects with no other medical or ocular conditions Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study: - 18 years of age or older - Presence of central or inferior steepening (on Pentacam topograph) - Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details) - Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam - I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map - Posterior corneal elevation \>16 microns (µm on Pentacam tomography) - Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography) - Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes - Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \>25% corneal thickness - 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 - Signed written willing to sign a consent form - Willingness and ability to comply with schedule for follow-up visits Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * healthy subjects with no other medical or ocular conditions Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study: * 18 years of age or older * Presence of central or inferior steepening (on Pentacam topograph) * Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details) * Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam * I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map * Posterior corneal elevation \>16 microns (µm on Pentacam tomography) * Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography) * Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes * Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \>25% corneal thickness * 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 * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: * active infections, collagen vascular disease, allergic to product All subjects meeting any of the following criteria will be excluded from this study: * Eyes classified as either normal or atypical normal on the severity grading scheme. * Corneal pachymetry at the screening exam that is \<300 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 cognitive or ambulatory conditions that would prevent eye drop compliance with medications * Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests. * Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

Treatments Being Tested

DEVICE

PXL Platinum 330 system

to determine the efficacy of riboflavin solution and UV light to treat cornea thinning conditions

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cohen Laser and Vision Center

Boca Raton, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05516004), the sponsor (Cohen Laser and Vision Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05516004 clinical trial studying?

This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05516004?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05516004?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05516004. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05516004. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.