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Sponsors and Collaborators: |
Federal University of São Paulo University of Sao Paulo Sorocaba Eye Bank |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00409955 |
Condition | Intervention | Phase |
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Keratoconus |
Procedure: Lamellar transplant with lyophilized corneas |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, SP | |
Federal University of Sao Paulo | |
São Paulo, SP, Brazil, 04023-062 |
Principal Investigator: | Roberta JM Farias, MD | Federal University of Sao Paulo |
Study ID Numbers: | CEP 1536/05 |
Study First Received: | December 11, 2006 |
Last Updated: | December 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00409955 History of Changes |
Health Authority: | Brazil: National Health Surveillance Agency |
Lamellar transplant Lyophilization Corneas storage |
Keratoconus patients Best corrected visual acuity < 20/60 Signed the consent inform |
Corneal Diseases Eye Diseases Keratoconus |
Corneal Diseases Eye Diseases Keratoconus |