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Procedure
Corneal Cross-Linking for Keratoconus
Phase 2
Recruiting
Research Sponsored by Goodman Eye Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
10 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test a new system for corneal cross-linking, a treatment for ectatic disorders. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for individuals with corneal ectasia conditions like keratoconus, showing specific signs such as Fleischer ring or Vogt's striae. Candidates must be 10 years or older and have a minimum corneal thickness. Those with previous significant eye diseases, less than required corneal thickness, or women who are pregnant/lactating cannot participate.Check my eligibility
What is being tested?
The PXL Platinum 330 system paired with Peschke riboflavin solution is being tested for its safety and effectiveness in treating ectatic disorders by strengthening the cornea through cross-linking.See study design
What are the potential side effects?
Potential side effects may include discomfort in the eye, temporary vision changes, risk of infection, inflammation inside the eye, and possible delayed healing of the treated area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
Select...
I am at least 10 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best-contact corrected visual acuity (BSCVA)
Secondary outcome measures
Keratometry
Uncorrected visual acuity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pusled, acceleratedExperimental Treatment1 Intervention
8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Group II: Pulsed, acceleratedExperimental Treatment1 Intervention
4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Goodman Eye CenterLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.My doctor thinks my current health condition won't affect my skin healing.I have had eye conditions that could complicate future treatments.I do not have conditions like nystagmus that make it hard to keep my gaze steady.I meet the specific eye condition criteria for this study.I am at least 10 years old.You are known to have a bad reaction or sensitivity to the medications used in the study.I have removed my contact lenses for the required time before my eye test.My eye condition shows signs like Fleischer ring or Munson's sign.
Research Study Groups:
This trial has the following groups:- Group 1: Pusled, accelerated
- Group 2: Pulsed, accelerated
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: NCT04094090 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are included in this research project?
"That is correct, the listing on clinicaltrials.gov does reveal that this trial has an open call for participants. This particular trial was first made public on October 19th, 2019 and had new information posted as recently as August 19th, 2020. They are looking to enroll 500 individuals at a single location."
Answered by AI
Has the PXL-330 Platinum device received FDA approval to be used in conjunction with Peschke riboflavin solution?
"The PXL-330 Platinum device for crosslinking with Peschke riboflavin solution is a new medical intervention, and as such has received a score of 2 in terms of safety."
Answered by AI
How is the PXL-330 Platinum device most commonly used in conjunction with Peschke riboflavin solution?
"The PXL-330 Platinum device, when used in conjunction with Peschke riboflavin solution, is a popular tool for dietary and nutritional therapies. However, it has also shown therapeutic value for treating vitamin deficiency, joint pain, and other ailments."
Answered by AI
Are patients being signed up for this clinical trial right now?
"This clinical trial is currently seeking participants. The trial was first posted on October 19, 2019 and was last updated on August 19, 2020."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
Goodman Eye Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have progressive KC in both eyes treated left in 2018 and needing treatment in right after condition worsening. Ideally help can keep me from further issues and help others dealing with my illness.
PatientReceived 2+ prior treatments
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