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Crosslinking Agent

Corneal Collagen Cross-Linking for Keratoconus

Phase 1
Waitlist Available
Research Sponsored by Cornea Associates of Texas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
8 years of age or older
Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
Must not have
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial found that the PXL-Platinum 330 system is safe and effective for corneal collagen cross-linking in eyes with corneal thinning conditions.

Who is the study for?
This trial is for people over 8 years old with certain corneal conditions like keratoconus or pellucid marginal degeneration. Participants must have specific measurements on eye scans and be willing to stop wearing contact lenses before tests if they use them. It's not for those with less than 300 microns of corneal thickness, a history of other eye diseases, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the PXL-330 Platinum device paired with Peschke riboflavin solution for strengthening the cornea in eyes that are thinning due to conditions like keratoconus. The goal is to see how safe and effective this crosslinking treatment is.See study design
What are the potential side effects?
While the description doesn't list side effects, typical ones from similar procedures may include temporary visual disturbances, discomfort or pain in the eye, potential infection risk, and possible long-term changes in vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 8 years old or older.
Select...
My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have conditions like nystagmus that affect my ability to keep my gaze steady.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
K-Max
K-Mean
Secondary outcome measures
Best Corrected Visual Acuity
Central Pachymetry
Uncorrected Visual Acuity

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pulsed 8mW/cm2Experimental Treatment1 Intervention
8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time
Group II: Pulsed 5mW/cm2Experimental Treatment1 Intervention
5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
2020
Completed Phase 1
~200

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cornea Associates of TexasLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Keratoconus
200 Patients Enrolled for Keratoconus

Media Library

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution (Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04667572 — Phase 1
Keratoconus Research Study Groups: Pulsed 5mW/cm2, Pulsed 8mW/cm2
Keratoconus Clinical Trial 2023: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution Highlights & Side Effects. Trial Name: NCT04667572 — Phase 1
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution (Crosslinking Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04667572 — Phase 1
Keratoconus Patient Testimony for trial: Trial Name: NCT04667572 — Phase 1
~24 spots leftby Aug 2024
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