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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00642044
• Other study ID #: 005/07-CEP
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2008
• Last updated: April 22, 2008
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2008
• Source: Universidade Federal do Rio de Janeiro
• Contact: Ricardo Lamy, MD
• Phone: 55-21-2714-7646
• Email: lamy[@]ufrj.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Corneal Collagen Crosslinking
UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.

Locations

Country	Name	City	State
Brazil	Clementino Fraga Filho University Hospital	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratometry		3 months	No
Primary	BSCVA (Best spectacle corrected visual acuity)		3 months	No
Secondary	Endothelial cell count		3 months	Yes

External Links

•   Clementino Fraga Filho University Hospital