Clinical trial NCT00832897: Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring
Official title: "Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
riboflavin
cornea
crosslinking
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Refractive data, visual acuity, topography patterns, pachymetry measurements.
timeFrame: Two years
Secondary outcomes:
measure: Anterior segment tomography data, corneal biomechanics, impression cytology.
timeFrame: Two years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Adimara C Renesto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Mauro S Campos, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Marta F Sartori, MD
role: STUDY_CHAIR
References:
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. doi: 10.1016/j.jcrs.2007.03.021.
citation: 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.
citation: Wollensak G, Spoerl E. Collagen crosslinking of human and porcine sclera. J Cataract Refract Surg. 2004 Mar;30(3):689-95. doi: 10.1016/j.jcrs.2003.11.032.
citation: Renesto Ada C, Melo LA Jr, Sartori Mde F, Campos M. Sequential topical riboflavin with or without ultraviolet a radiation with delayed intracorneal ring segment insertion for keratoconus. Am J Ophthalmol. 2012 May;153(5):982-993.e3. doi: 10.1016/j.ajo.2011.10.014. Epub 2012 Jan 20.