Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Not Applicable

• Conditions: Keratoconus
• Interventions: Procedure: Corneal Collagen Crosslinking

• Registration Number: NCT00642044
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Last Update Submitted: 2008-04-22
• Last Update Posted: 2008-04-23
• Primary Completion: 2008-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age from 18 to 35 years.
• Diagnosis of Keratoconus.
• Progression of Ametropia.
• Written informed consent.

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Exclusion Criteria

• Corneal Thickness < 395 micra at thinnest point.
• Other active ocular disease than keratectasia.
• Cornea Guttata.
• Previous ocular surgery.
• Pregnancy.
• Known sensitivity to riboflavin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Corneal Collagen Crosslinking	The eye with the worst visual acuity receives the treatment. (the other eye serve as control).

Primary Outcome Measures

Name	Time	Method
Keratometry	3 months
BSCVA (Best spectacle corrected visual acuity)	3 months

Secondary Outcome Measures

Name	Time	Method
Endothelial cell count	3 months

Trial Locations

Locations (1)

Clementino Fraga Filho University Hospital; 🇧🇷 Rio de Janeiro, RJ, Brazil