Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring

Keratoconus Clinical Trial

Official title:

"Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832897
• Other study ID #: 1915/07
• Status: Completed
• Phase: N/A
• First received: January 29, 2009
• Last updated: January 6, 2011
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: January 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to postpone the corneal transplantation in keratoconus and promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking , and after, corneal ring surgery.

Description:

Keratoconus is a progressive disease where cornea is thin and has a higher curvature.In early conditions, it may be corrected by glasses or contact lens.When these possibilities are not more possibles, it may be corrected by corneal ring surgery ore corneal transplantation depending your degree.

In this study, the patients with a degree of keratoconus on I or II, will be submitted to corneal collagen crosslinking and then a corneal ring surgery.

The corneal collagen crosslinking promote the stiffness of the cornea across the riboflavin-UVA irradiation, avoid the progression of the keratoconus.After three months of crosslinking, these patients will be submitted a corneal ring surgery.

These patients will be allowed by two years and various exams will realized them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with keratoconus

• Patients that aren't using contact lenses

• Pachymetry more than 400Um

• Best visual acuity less or equal 20/30

Exclusion Criteria:

• Ocular surgeries before

• Other eye diseases

• Corneal curvature more than 65 dioptres

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Corneal collagen crosslinking
The patients will be submitted to corneal collagen crosslinking, that consists: Instillation of riboflavin eyedrop in the cornea for thirty minutes, and after, the patient will stay under the Crosslinking equipment, for more thirty minutes, also receiving riboflavin eyedrop.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Coskunseven E, Kymionis GD, Tsiklis NS, Atun S, Arslan E, Jankov MR, Pallikaris IG. One-year results of intrastromal corneal ring segment implantation (KeraRing) using femtosecond laser in patients with keratoconus. Am J Ophthalmol. 2008 May;145(5):775-9. doi: 10.1016/j.ajo.2007.12.022. Epub 2008 Mar 4. — View Citation

Mencucci R, Mazzotta C, Rossi F, Ponchietti C, Pini R, Baiocchi S, Caporossi A, Menchini U. Riboflavin and ultraviolet A collagen crosslinking: in vivo thermographic analysis of the corneal surface. J Cataract Refract Surg. 2007 Jun;33(6):1005-8. — View Citation

Wollensak G, Spoerl E. Collagen crosslinking of human and porcine sclera. J Cataract Refract Surg. 2004 Mar;30(3):689-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive data, visual acuity, topography patterns, pachymetry measurements.		Two years	Yes
Secondary	Anterior segment tomography data, corneal biomechanics, impression cytology.		Two years	Yes