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Completed

NCT Number: NCT00832897

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04038-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corneal collagen crosslinking

Procedure

The patients will be submitted to corneal collagen crosslinking, that consists:

Instillation of riboflavin eyedrop in the cornea for thirty minutes, and after, the patient will stay under the Crosslinking equipment, for more thirty minutes, also receiving riboflavin eyedrop.

Other names: Keratoconus., Corneal collagen crosslinking.

Primary outcomes

  1. Refractive data, visual acuity, topography patterns, pachymetry measurements.

    Time frame: Two years

Secondary outcomes

  1. Anterior segment tomography data, corneal biomechanics, impression cytology.

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

"Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Jan 30, 2009
Registry last updated
Jan 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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