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

Federal University of São Paulo

Status: Completed

Conditions: Keratoconus

Treatments: Procedure: Corneal collagen crosslinking

Study type: Interventional

Funder types: Other

Identifiers

NCT00832897

1915/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Eyedrop

Sham Comparator group

Treatment:

Procedure: Corneal collagen crosslinking

Crosslinking

Active Comparator group

Description:

The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.

Treatment:

Procedure: Corneal collagen crosslinking