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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01097447 |
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Date of registration:
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25/03/2010 |
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Primary sponsor: |
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Public title:
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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
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Scientific title:
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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01097447 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Jenna Piel |
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Address:
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Telephone:
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951-653-5566 |
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Email:
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Affiliation:
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Name:
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Jenna Piel |
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Address:
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Telephone:
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951-653-5566 |
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Email:
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j.piel@imedsonline.com |
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Affiliation:
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Name:
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Parag Majmudar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chicago Cornea Consultants, LTD |
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Name:
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Sandy Feldman, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clear View Eye & Laser Medical Center |
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Name:
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Bradley Bowman, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cornea Associates of Texas |
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Name:
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Lance Forstot, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Corneal Consultants of Colorado, P.C |
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Name:
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David Wallace, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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LA Sight |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 8 years of age or older
- Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or
forme fruste pellucid marginal degeneration.
- Diagnosis of FFKC
- History of Radial Keratotomy with fluctuating vision.
- Ability to provide written informed consent
- Likely to complete all study visits
- Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam
Exclusion Criteria:
- Severe corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
Age minimum:
8 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Degeneration
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Ectasia
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Keratoconus
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Primary Outcome(s)
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Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
[Time Frame: 1 year]
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Secondary Outcome(s)
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increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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