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Sponsored by: |
Federal University of Rio de Janeiro |
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Information provided by: | Federal University of Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT00642044 |
Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.
Condition | Intervention |
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Keratoconus |
Procedure: Corneal Collagen Crosslinking |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study |
Official Title: | Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study |
Estimated Enrollment: | 100 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
The eye with the worst visual acuity receives the treatment. (the other eye serve as control).
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Procedure: Corneal Collagen Crosslinking
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
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B: No Intervention
The eye with the best visual acuity do not receive the treatment.
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ricardo Lamy, MD | 55-21-2714-7646 | lamy@ufrj.br |
Brazil, RJ | |
Clementino Fraga Filho University Hospital | Recruiting |
Rio de Janeiro, RJ, Brazil, 21941-913 | |
Contact: Ricardo Lamy lamy@ufrj.br | |
Principal Investigator: Ricardo Lamy, MD |
Principal Investigator: | Ricardo Lamy, MD | UFRJ |
Responsible Party: | UFRJ - Department of Ophthalmology ( Adalmir Morterá Dantas / Department of Ophthalmology Chief ) |
Study ID Numbers: | 005/07-CEP |
Study First Received: | March 17, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00642044 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Keratoconus |
Corneal Diseases Riboflavin Eye Diseases Tetrahydrozoline Keratoconus |
Photosensitizing Agents Vitamin B Complex Radiation-Sensitizing Agents Growth Substances Vitamins |
Therapeutic Uses Physiological Effects of Drugs Micronutrients Dermatologic Agents Pharmacologic Actions |