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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Universidade Federal do Rio de Janeiro.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00642044
First received: March 17, 2008
Last updated: April 22, 2008
Last verified: March 2008
  Purpose

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 Intervention
Keratoconus
Procedure: Corneal Collagen Crosslinking

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Keratometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • BSCVA (Best spectacle corrected visual acuity) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial cell count [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: March 17, 2008
Last Updated: April 22, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
Keratoconus

Additional relevant MeSH terms:
Riboflavin
Keratoconus
Corneal Diseases
Eye Diseases
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 April 16, 2014