Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Keratometry [3 months]
- BSCVA (Best spectacle corrected visual acuity) [3 months]
Secondary Outcome Measures
- Endothelial cell count [3 months]
Eligibility Criteria
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.
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Cornea Guttata.
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Previous ocular surgery.
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Pregnancy.
-
Known sensitivity to riboflavin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clementino Fraga Filho University Hospital | Rio de Janeiro | RJ | Brazil | 21941-913 |
Sponsors and Collaborators
- Universidade Federal do Rio de Janeiro
Investigators
- Principal Investigator: Ricardo Lamy, MD, UFRJ
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- Spoerl E, Huhle M, Seiler T. Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103.
- 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. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7.
- 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.
- 005/07-CEP