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Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

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ClinicalTrials.gov Identifier: NCT00642044
Recruitment Status : Unknown
Verified March 2008 by Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : March 24, 2008
Last Update Posted : April 23, 2008
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro

Brief Summary:
Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Corneal Collagen Crosslinking Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
Study Start Date : February 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
The eye with the worst visual acuity receives the treatment. (the other eye serve as control).
Procedure: Corneal Collagen Crosslinking
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.
No Intervention: B
The eye with the best visual acuity do not receive the treatment.



Primary Outcome Measures :
  1. Keratometry [ Time Frame: 3 months ]
  2. BSCVA (Best spectacle corrected visual acuity) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Endothelial cell count [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 18 to 35 years.
  • Diagnosis of Keratoconus.
  • Progression of Ametropia.
  • Written informed consent.

Exclusion Criteria:

  • Corneal Thickness < 395 micra at thinnest point.
  • Other active ocular disease than keratectasia.
  • Cornea Guttata.
  • Previous ocular surgery.
  • Pregnancy.
  • Known sensitivity to riboflavin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642044


Contacts
Contact: Ricardo Lamy, MD 55-21-2714-7646 lamy@ufrj.br

Locations
Brazil
Clementino Fraga Filho University Hospital Recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Contact: Ricardo Lamy       lamy@ufrj.br   
Principal Investigator: Ricardo Lamy, MD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Ricardo Lamy, MD UFRJ

Additional Information:
Publications:
Responsible Party: Adalmir Morterá Dantas / Department of Ophthalmology Chief, UFRJ - Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00642044     History of Changes
Other Study ID Numbers: 005/07-CEP
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: April 23, 2008
Last Verified: March 2008

Keywords provided by Universidade Federal do Rio de Janeiro:
Keratoconus

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents