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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00832897
First received: January 29, 2009
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Keratoconus
 Procedure: Corneal collagen crosslinking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Refractive data, visual acuity, topography patterns, pachymetry measurements. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anterior segment tomography data, corneal biomechanics, impression cytology. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Eyedrop Procedure: Corneal collagen crosslinking

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.
Active Comparator: Crosslinking
The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.
 Procedure: Corneal collagen crosslinking

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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832897

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04038-000
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Adimara C Renesto, MD Federal University of São Paulo
Study Chair: Mauro S Campos, MD Federal University of São Paulo
Study Chair: Marta F Sartori, MD Federal University of São Paulo
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00832897     History of Changes
Other Study ID Numbers: 1915/07
Study First Received: January 29, 2009
Last Updated: January 6, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Keratoconus
riboflavin
cornea
crosslinking

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013