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This trial will test how effective and safe a corneal collagen cross-linking is at two different energy levels.
- Corneal Ectasia
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have a current condition that could delay or interfere with the healing of your skin.You have taken Vitamin C supplements within a week before the cross-linking treatment.You have had a type of eye surgery called keratorefractive procedure in the past.Your cornea is too thin.You are allergic or sensitive to the medications used in the study.You have a condition that makes it difficult for you to keep a steady gaze during treatment, such as nystagmus.You cannot lie down comfortably for a long time or cannot tolerate a device called a lid speculum.
- Group 1: 9 mW/cm2
- Group 2: 18 mW/cm2
- 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.
Frequently Asked Questions
Is this research actively recruiting participants?
"According to clinicaltrials.gov, this trial has ceased recruiting participants, with the last update occurring on December 10th 2015. Nevertheless, a total of 92 other medical studies are currently looking for patients right now."
What is the upper limit on enrollees for this clinical investigation?
"At present, this clinical trial is not seeking to enrol more participants. It was first listed in October 2013 before the most recent update on December 10th 2015. For those searching for related trials, there are 75 studies concerning keratoconus and 17 experiments involving 9 mW/cm2 that require additional patients."
Have there been any studies that have utilized 9 mW/cm2 to date?
"Currently, of all the studies examining 9 mW/cm2, 8 are in Phase 3 with 17 trials still active. Furthermore, there is a total of 44 research centres conducting these investigations; the most being based out of San Francisco, Californiaf all the studies examining 9 mW/cm2, 8 are in Phase 3 with 17 trials still active. Furthermore, there is a total of 44 research centres conducting these investigations; the most being based out of San Francisco, California."
Does a 9 mW/cm2 radiation exposure pose any health risks?
"Due to the limited clinical data on 9 mW/cm2, it was assigned a safety score of 1. This is expected as this trial currently only in Phase 1 and there is little evidence supporting its efficacy or safety."
Who is authorized to partake in this clinical experiment?
"This clinical trial seeks 100 individuals of legal age and suffering from keratoconus. To be eligible, participants must demonstrate an aptitude for following the study's timeline, have recently removed their contact lenses, display a shift in myopia of at least 0.50 D on refraction testing, exhibit central or inferior steepening in Pentacam mapping results, as well as hold astigmatism measurements that reflect an increase of 1.00 D or more from manifest refraction tests."
Does this research entail recruiting individuals aged 30 or older?
"All applicants to this clinical trial must meet the age requirements of 18 years or older and no more than 80 upon enrollment."
What conditions are ameliorated by the application of 9 mW/cm2?
"9 mW/cm2 is a viable approach to address dietary deficiencies, nutrition-based treatments and joint discomfort."
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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