Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Procedure: Corneal collagen crosslinking

• Registration Number: NCT00832897
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to postpone the corneal transplantation in keratoconus and promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking , and after, corneal ring surgery.

Detailed Description

Keratoconus is a progressive disease where cornea is thin and has a higher curvature.In early conditions, it may be corrected by glasses or contact lens.When these possibilities are not more possibles, it may be corrected by corneal ring surgery ore corneal transplantation depending your degree.

In this study, the patients with a degree of keratoconus on I or II, will be submitted to corneal collagen crosslinking and then a corneal ring surgery.

The corneal collagen crosslinking promote the stiffness of the cornea across the riboflavin-UVA irradiation, avoid the progression of the keratoconus.After three months of crosslinking, these patients will be submitted a corneal ring surgery.

These patients will be allowed by two years and various exams will realized them.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-11
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Study Completion: 2010-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients with keratoconus
• Patients that aren't using contact lenses
• Pachymetry more than 400Um
• Best visual acuity less or equal 20/30

Exclusion Criteria

• Ocular surgeries before
• Other eye diseases
• Corneal curvature more than 65 dioptres

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eyedrop	Corneal collagen crosslinking	-
Crosslinking	Corneal collagen crosslinking	The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.

Primary Outcome Measures

Name	Time	Method
Refractive data, visual acuity, topography patterns, pachymetry measurements.	Two years

Secondary Outcome Measures

Name	Time	Method
Anterior segment tomography data, corneal biomechanics, impression cytology.	Two years

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil