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Collagen Cross-Linking for Keratoconus
Study Summary
This trial will test how effective and safe a corneal collagen cross-linking is at two different energy levels.
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 never had chemical eye injuries or slow healing in my eyes.My eye condition matches keratoconus patterns.I have had eye surgery to correct my vision.My cornea is thinner than normal.My vision isn't as good even with my best glasses.I am 18 years old or older.I can remove my contact lenses before evaluation and treatment.I have been diagnosed with progressive keratoconus.My vision has worsened by at least half a diopter due to keratoconus.My cornea's thinnest part has shifted position.My vision is getting worse, becoming more nearsighted.My eyes have developed irregular astigmatism.I can attend all scheduled follow-up visits.I have not taken Vitamin C supplements in the last week.I do not have nystagmus or any condition that affects my ability to maintain a steady gaze.I do not have a condition that slows down skin healing.I have had eye surgery to correct my vision.I am 18 years old or older.My condition is worsening keratoconus.My cornea is thinner than normal.My eye condition is diagnosed as keratoconus.
- Group 1: 9 mW/cm2
- Group 2: 18 mW/cm2
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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, 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."
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