Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study|
- Keratometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- BSCVA (Best spectacle corrected visual acuity) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Endothelial cell count [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|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)|
The eye with the worst visual acuity receives the treatment. (the other eye serve as control).
Procedure: Corneal Collagen Crosslinking
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
No Intervention: B
The eye with the best visual acuity do not receive the treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642044
|Contact: Ricardo Lamy, MDfirstname.lastname@example.org|
|Clementino Fraga Filho University Hospital||Recruiting|
|Rio de Janeiro, RJ, Brazil, 21941-913|
|Contact: Ricardo Lamy email@example.com|
|Principal Investigator: Ricardo Lamy, MD|
|Principal Investigator:||Ricardo Lamy, MD||UFRJ|