Biosilicate implant evaluation in anophthalmic socket

• Grant number: 13/00131-8
• Support Opportunities: Regular Research Grants
• Start date: May 01, 2013
• End date: January 31, 2016
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Silvana Artioli Schellini
• Grantee: Silvana Artioli Schellini
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
• Associated researchers: Oscar Peitl Filho ; Simone Milani Brandão ; Suzana Matayoshi

Abstract

The replacement of the volume in the anophthalmic cavities are made for many years. Glass was the first material used for this purpose. The bioglass and biovitroceramic were introduced recently in some areas of medicine, raising the hypothesis of using these materials to repair the lack of volume in anophthalmic sockets, experimental studies were performed by the group that will work on this project that aims to assess biosilicate implant in rabbit anophthalmic sockets. The project is justified by the shortage of brazilian materials to be used in the reconstruction of anophthalmic sockets.Purpose: we intend to evaluate in humans biosilicate implants for volume replacement in anophthalmic sockets after evisceration or enucleation.Material and Methods: This is a phase III study. It is intended to use implants in conical shape, made of biosilicate, to be placed in cavities eviscerated or enucleated who have an indication of the surgical procedure and with their consent. The study will be conducted at the Faculdade de Medicina de Botucatu and the Faculdade de Medicina of the USP-São Paulo. The patients should have anophthalmic cavities Grade 1. Sixty patients were estimated to participate, of which 40 will receive biosilicate cones and 20 polymethylmethacrylate cones for volume replacement of anophthalmic socket. We considered 10% of loss during the study follow-up. After surgery, patients will be followed for seven, 15, and 30 days after every three months, for a period of one year. Systemic parameters to be evaluated are: clinical examination (evaluation of the orbital cavity and systemic), biochemical tests (SGOT, SGPT, CPK, ALP, LDH, BUN and creatinine) and tomographic evaluation of the orbit. Results will be evaluated using statistical methods. (AU)

Filed patent(s) as a result of this research project