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Corneal Collagen Crosslinking + Intacs for Keratoconus (CXL Trial)
CXL Trial Summary
This trial will compare two procedures for treating keratoconus, a degenerative eye disease. One procedure uses a collagen crosslinking, while the other uses Intacs. The goal is to determine which procedure is more effective.
CXL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCXL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CXL Trial Design
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Who is running the clinical trial?
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- I am 21 years old or older.I have been diagnosed with keratoconus or corneal ectasia after having eye surgery like LASIK.My eye condition is related to keratoconus or corneal ectasia after surgery.I have had an eye condition that could cause future problems.I have had a corneal disease in the past.I can keep my gaze steady during eye treatments and tests.My current health condition could slow down my skin healing.I have had a chemical injury or slow healing in my eye.
- Group 1: Intacs combined with CXL
- Group 2: Intacs followed by CXL
- 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
Do the benefits of Intacs and CXL outweigh any risks for patients?
"Intacs combined with CXL is rated as a 3 on our Power team's safety scale. This is due to the fact that it is a Phase 3 trial, which means there is some evidence of its efficacy and multiple rounds of data supporting its safety."
What is the common reason that people take Intacs in combination with CXL?
"Using a combination of Intacs and CXL, patients can see improvement in dietary and nutritional therapies, vitamin deficiency, and joint pain."
How many people are eligible for this clinical trial?
"This study is no longer recruiting participants. The listing was created on 4/1/2010 and most recently updated on 3/7/2022. For those seeking other trials, there are currently 90 trials actively recruiting patients with keratoconus and 20 for Intacs combined with CXL."
Are there any other notable studies that have looked at Intacs in tandem with CXL?
"20 clinical studies are actively researching the efficacy of Intacs in conjunction with CXL. The majority of these trials, 11 in total, are currently in Phase 3. However, there are 47 active trial locations for Intacs combined with CXL across the globe—not just San Francisco, California."
Are we still able to enroll patients in this experiment?
"Unfortunately, this study is no longer looking for participants. The clinical trial was originally advertised on April 1st 2010 and received its last update on March 7th 2022. However, there are other ongoing trials that may be of interest; including 90 studies searching for patients with keratoconus and 20 Intacs combined with CXL studies still recruiting individuals."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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