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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
Information provided by:
Universidade Federal do Rio de Janeiro Identifier:
First received: March 17, 2008
Last updated: April 22, 2008
Last verified: March 2008
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
Procedure: Corneal Collagen Crosslinking

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 ]
  • BSCVA (Best spectacle corrected visual acuity) [ Time Frame: 3 months ]

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

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00642044

Contact: Ricardo Lamy, MD 55-21-2714-7646

Clementino Fraga Filho University Hospital Recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Contact: Ricardo Lamy   
Principal Investigator: Ricardo Lamy, MD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Principal Investigator: Ricardo Lamy, MD UFRJ
  More Information

Additional Information:
Responsible Party: Adalmir Morterá Dantas / Department of Ophthalmology Chief, UFRJ - Department of Ophthalmology Identifier: NCT00642044     History of Changes
Other Study ID Numbers: 005/07-CEP
Study First Received: March 17, 2008
Last Updated: April 22, 2008

Keywords provided by Universidade Federal do Rio de Janeiro:

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents processed this record on May 22, 2017