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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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 belowSelect...
I am 8 years old or older.
Select...
My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or have a known sensitivity to the study medications.I do not have conditions like nystagmus that affect my ability to keep my gaze steady.I am 8 years old or older.My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.I have had eye conditions that could complicate treatment, excluding vision correction issues.My eye condition shows signs like Fleischer ring or Munson's sign.I can stop wearing my contact lenses before the eye test as required.You have a medical condition that may slow down or disrupt the healing process of your skin or other tissues.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed 5mW/cm2
- Group 2: Pulsed 8mW/cm2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Keratoconus Patient Testimony for trial: Trial Name: NCT04667572 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA recognize PXL-330 Platinum device and Peschke riboflavin solution as a viable combination for crosslinking treatments?
"PXL-330 Platinum device combined with Peschke riboflavin solution has limited data confirming efficacy and safety, so it earned a score of 1."
Answered by AI
Is this research venture recruiting participants at present?
"Per the details found on clinicaltrials.gov, this medical experiment is still searching for participants. The trial was initially posted to the database on February 1st 2021 and has been amended as recently as September 14th 2022."
Answered by AI
What is the present size of the cohort in this trial?
"Affirmative. Evidence on clinicaltrials.gov reveals that this research endeavor, which was first uploaded to the platform on February 1st 2021, is actively looking for participants. Approximately 1000 individuals need to be recruited from one location."
Answered by AI
To what maladies is the PXL-330 Platinum device in conjunction with Peschke riboflavin solution typically applied?
"The PXL-330 Platinum device, when paired with Peschke riboflavin solution, is typically used in dietary and nutritional therapies. However, it may be employed to relieve joint pain or supplement vitamin intake for those suffering from deficiencies."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
California
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Cornea Associates of Texas
How many prior treatments have patients received?
0
Why did patients apply to this trial?
My mother is contacting organizations for help. We don't have medical insurance and can't afford medical treatment. Vision is extremely bad and is getting worse. I am limited on what I can do for employment and recently got injured on the job. We need help!
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Are there any costs?
PatientReceived no prior treatments
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