Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
Study Details
Study Description
Brief Summary
To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Ciprofloxicine or Vigamox or other up to qid till epithelialized. |
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Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom up to qid for up to 5-10 days postop |
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Topical steroid (FML, Pred Forte, Flarex qid for up to 8 weeks |
Outcome Measures
Primary Outcome Measures
- Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [1 year]
Secondary Outcome Measures
- increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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8 years of age or older
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Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
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Diagnosis of FFKC
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History of Radial Keratotomy with fluctuating vision.
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Ability to provide written informed consent
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Likely to complete all study visits
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Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam
Exclusion Criteria:
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Severe corneal scarring that markedly affects vision
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Contraindications to any study medications or their components
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Pregnancy or breast feeding
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Active Herpes Corneal Disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clear View Eye & Laser Medical Center | San Diego | California | United States | 92121 |
2 | Corneal Consultants of Colorado, P.C | Littleton | Colorado | United States | |
3 | Chicago Cornea Consultants, LTD | Hoffman Estates | Illinois | United States | |
4 | Minnesota Eye Consultants, P.A. | Bloomington | Minnesota | United States | 55431 |
5 | Cornea Associates of Texas | Dallas | Texas | United States | 75231 |
Sponsors and Collaborators
- Cxlusa
Investigators
- Principal Investigator: Parag Majmudar, MD, Chicago Cornea Consultants, LTD
- Principal Investigator: Lance Forstot, MD, Corneal Consultants of Colorado, P.C
- Principal Investigator: Bradley Bowman, M.D, Cornea Associates of Texas
- Principal Investigator: Sandy Feldman, M.D, Clear View Eye & Laser Medical Center
- Principal Investigator: Sherman Reeves, MD, Minnesota Eye Consultants, P.A.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CXL (2)