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Corneal Collagen Crosslinking for Keratoconus
Study Summary
This trial is testing whether a new crosslinking technique can better maintain corneal thickness, potentially leading to better results.
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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- I have noticeable scarring on my cornea where I received CXL treatment.I have had an eye condition that could cause future problems.I do not have conditions like nystagmus that make it hard to keep my gaze steady.My eye condition has worsened in the last 2 years or occurred after eye surgery.I am 18 years old or older.
- Group 1: Riboflavin/dextran
- Group 2: Hypotonic Riboflavin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Are there other instances where Hypotonic Riboflavin has been tested in a controlled setting?
"There are presently 21 ongoing studies for Hypotonic Riboflavin, with the majority of them being in Phase 3. Out of the 47 total clinical trial locations for this medication, most of them are situated in Teaneck, New jersey."
Are there any current openings for participants in this clinical trial?
"Unfortunately, this trial is not currently looking for new participants. It was originally posted on 6/1/2010 but the most recent update was on 3/7/2022. However, there are 81 trials actively enrolling patients with keratoconus and 21 studies for Hypotonic Riboflavin that are admitting new patients if you explore other options."
What are the primary issues that Hypotonic Riboflavin addresses?
"Hypotonic Riboflavin is often used to replenish vitamin deficiencies. However, it has also been shown to ameliorate symptoms of dry eyes, pulmonary embolism, and fluorophotometry."
How many people are consenting to participate in this experiment?
"Recruitment for this particular trial has ceased. The study was originally advertised on 6/1/2010 and updated as recently as 3/7/2022. For individuals searching for other studies, there are 81 trials admitting participants with keratoconus and 21 studies for Hypotonic Riboflavin that active recruiting right now."
Has the FDA given their seal of approval to Hypotonic Riboflavin?
"There is some evidence that Hypotonic Riboflavin is effective, as this is a Phase 3 trial. Furthermore, there is ample safety data from multiple sources, so it received a score of 3."
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