View Clinical Trial (Medical Research Study)
Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.
| City: |
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Amherst |
| State: |
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New York |
| Zip Code: |
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14228 |
| Conditions: |
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Keratoconus |
| Purpose: |
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The purpose of this study is to determine the effectiveness of collagen cross-linking in the
cornea in halting the progression and possibly partially reversing the effects of
keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular
astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in
more advanced cases, scarring of the cornea that may lead to the need for corneal
transplantation. Cross-linking has been shown increase the rigidity of the cornea. The
patients would be treated once and then followed over 24 months. .
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| Study Summary: |
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The goal is for two groups of approximately 66 patients to be included in the study. One
eye from the first group will undergo treatment, while the second group of age matched
individuals will serve as a control. It will be a prospective, randomized, blinded study.
Each patient will be randomized at the beginning of enrollment in the study and will receive
a randomization number. The following parameters will be followed: 1. Best corrected
spectacle acuity (BCSA) 2. The steepest keratometry measurement (KMax) as measured by
computerized corneal topography 3. Apical corneal thickness 4. Corneal mechanical
resistance. These measurements will be repeated at 1 month, 3 months, 6 months, 12, 18, and
24 months following treatment.
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| Criteria: |
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Inclusion Criteria:
- no prior history of ocular surgery
- treatment eye must have a maximum corneal power of between 47 D and 60 diopters
- corneal thickness must be greater than 400 µ
- absence of corneal scarring
- patients must meet the diagnostic criteria for keratoconus, which include one or more
of the following features:
- high myopia
- corneal ectasia as viewed by slit-lamp exam or measured by pachometry
- Vogt's striae
- topographic findings of superior flattening and inferior steepening of the
cornea
- presence of Fleischer ring
Exclusion Criteria:
- history of prior ocular surgery (history of contact lens use is not an exclusion
criterion)
- average corneal power > 60 D
- presence of corneal scarring
- corneal thickness 400 µ or less
- history of herpes simplex virus keratitis
- history of uveitis
- pre-existing glaucoma
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| NCT ID: |
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NCT00841386 |
| Primary Contact: |
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Principal Investigator
James J Reidy, M.D.
SUNY at Buffalo School of Medicine & Biomedical Sciences
James J. Reidy, M.D.
Phone: 716-881-7920
Email: jreidymd@mac.com
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| Backup Contact: |
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Email: jstutz@buffalo.edu
Jeanne Stutz
Phone: 716-881-7920
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| Location Contact: |
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Amherst, New York 14228
United States
Linda Grant, C.O.M.T.
Phone: 716-564-2020
Email: linda.grant@fichte.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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