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Corneal Collagen Cross-Linking for Keratoconus
Study Summary
This trial is testing a new system to treat corneal thinning conditions to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a known sensitivity or allergy to the medications used in the study.My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.You have a condition called Fleischer ring.My eye shows a bulging sign when looking down.My eye can focus on a close object when covered.I have a history of or currently have a corneal disease.Your cornea is not centered properly.I am having eye surgery and my eye measurements meet specific criteria.I have removed my contact lenses as instructed before the eye test.The topography shows a crab-claw shape.My doctor thinks my condition could slow down my skin healing.My eye infection hasn't improved after 2 weeks of treatment or my cornea is quickly getting thinner.I have streaks in the eye's clear covering.I have significant scarring on my cornea that is not due to keratoconus and may affect treatment.My AvaGen test shows I'm at high risk for keratoconus.I meet the specific eye condition criteria for this study.I don't have conditions like nystagmus that make it hard to keep my gaze steady.My eyes have conditions that could risk future complications.I am 12 years old or older.I have signs of keratoconus or pellucid marginal degeneration.You can keep wearing your scleral lenses during the study, unless your eyes show signs of low oxygen levels, like new blood vessels forming on your cornea.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- Group 1: Conventional
- Group 2: Pulsed, accelerated
Frequently Asked Questions
What are the potential risks associated with Peschke ribofflavin solution and PXL-330 Platinum device crosslinking?
"The safety of the PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution is estimated at a 1 due to its Phase 1 clinical trial status; This indicates that only limited data exists in support of efficacy and safety."
How many participants are currently taking part in this medical experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this investigation is currently recruiting participants with an initial posting date of September 1st 2019 and a recent update occurring on September 14th 2021. In total, 300 patients are needed at one medical centre for the study's completion."
Does this trial include participants older than thirty years?
"According to the trial's stipulations, potential participants need to be between 10 and 45 years old."
Who is authorized to partake in this scientific experiment?
"This clinical trial is seeking 300 patients with keratoconus aged 10 to 45. To be eligible for the study, applicants must possess an unstable form of the condition."
Are there any vacancies for those interested in joining this experiment?
"Affirmative, according to clinicaltrials.gov this research study is still looking for participants. It was first advertised on September 1st 2019 and last updated two years later on September 14th 2021. 300 volunteers are needed from a single site."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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