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

January 6, 2011 updated by: Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04038-000
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Refractive data, visual acuity, topography patterns, pachymetry measurements.
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Anterior segment tomography data, corneal biomechanics, impression cytology.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (ESTIMATE)

January 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1915/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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