Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study - Full Text View

Sponsored by:	Federal University of Rio de Janeiro
Information provided by:	Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:	NCT00642044

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

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Riboflavin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study
Official Title:	Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Further study details as provided by Federal University of 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
A: Experimental 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.
B: No Intervention 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, RJ
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

Federal University of Rio de Janeiro

Investigators

Principal Investigator:

Ricardo Lamy, MD

UFRJ

More Information

Clementino Fraga Filho University Hospital This link exits the ClinicalTrials.gov site

Publications:

Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7.

Spoerl E, Huhle M, Seiler T. Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103.

Kolozsvári L, Nógrádi A, Hopp B, Bor Z. UV absorbance of the human cornea in the 240- to 400-nm range. Invest Ophthalmol Vis Sci. 2002 Jul;43(7):2165-8.

Sekundo W, Stevens JD. Surgical treatment of keratoconus at the turn of the 20th century. J Refract Surg. 2001 Jan-Feb;17(1):69-73.

Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45.

Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. Review.

Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced cross-linking. J Cataract Refract Surg. 2003 Sep;29(9):1780-5.

Responsible Party:	UFRJ - Department of Ophthalmology ( Adalmir Morterá Dantas / Department of Ophthalmology Chief )
Study ID Numbers:	005/07-CEP
Study First Received:	March 17, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00642044
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:

Keratoconus

Study placed in the following topic categories:

Corneal Diseases
Riboflavin
Eye Diseases
Tetrahydrozoline
Keratoconus

Additional relevant MeSH terms:

Photosensitizing Agents
Vitamin B Complex
Radiation-Sensitizing Agents
Growth Substances
Vitamins

Therapeutic Uses
Physiological Effects of Drugs
Micronutrients
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009