Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring
NCT ID: NCT00832897
Last Updated: 2011-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2008-03-31
2010-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eyedrop
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.
Crosslinking
The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients that aren't using contact lenses
* Pachymetry more than 400Um
* Best visual acuity less or equal 20/30
Exclusion Criteria
* Other eye diseases
* Corneal curvature more than 65 dioptres
ALL
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Federal University of São Paulo
Principal Investigators
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Adimara C Renesto, MD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Mauro S Campos, MD
Role: STUDY_CHAIR
Federal University of São Paulo
Marta F Sartori, MD
Role: STUDY_CHAIR
Federal University of São Paulo
Locations
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Federal University of São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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1915/07
Identifier Type: -
Identifier Source: org_study_id
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