ABSTRACT A novel locally manufactured and developed porous hydroxyapatite orbital implant has been investigated and found to be as safe as commercially available implants. Objective To describe and analyze the results of twenty orbital implants implanted into patients in one arm of a multicentre trial. Methods A porous hydroxyapatite orbital implant with a smooth cap was developed and implanted into twenty patients. These patients were followed up for a period of four months. Patients were examined for signs of infection or extrusion of the implants. The amount of post-operative pain, chemosis, granuloma formation and vascularity was also assessed. Results None of the twenty patients had any signs of extrusion or infection at the termination of the study. There was very little pain or chemosis noted and no granuloma formation. Conclusion The locally developed implants were safe in anophthalmic eyes when reviewed after a four month follow-up period.

O objetivo do presente estudo foi avaliar a resposta tecidual e clínica a um implante orbitário de polimetilmetacrilato (PMMA), oco e multiperfurado em sua porção posterior em modelo animal de evisceração. Dezesseis coelhos da raça Nova Zelândia foram submetidos à evisceração do globo ocular direito. Todos receberam implante de polimetilmetacrilato de 12 mm de diâmetro multiperfurado em sua semiesfera posterior. O estudo foi dividido em avaliação clínica e histopatológica. A avaliação clínica foi diária até 14 dias pós-evisceração e, a cada sete dias, até completar 180 dias. Os animais foram divididos em grupos de quatro animais e cada um foi submetido à exenteração com 07, 30, 90 e 180 dias e depois à eutanásia. A análise histopatológica teve por fim caracterizar o padrão inflamatório, a estrutura do colágeno e o grau de neovascularização. Para isso, além da tradicional coloração pela hematoxilina-eosina (HE), utilizou-se o corante Picrosirius Red (PSR) e imunohistoquímica com o marcador CD34. Não houve sinais de infecção, exposição ou extrusão do implante em nenhum animal durante o estudo. Já no sétimo dia, o tecido neoformado migrou para dentro do implante formando uma rede fibrovascular através dos canais posteriores. A resposta inflamatória diminuiu ao longo do tempo avaliado e não foram encontradas células gigantes multinucleadas. O implante analisado é biocompatível, inerte e sua estrutura permite a sua integração aos tecidos orbitários pelo crescimento fibrovascular. / The objective of the present study was to evaluate the tissue and clinical response to a hollow and multiperforated polymethylmethacrylate (PMMA) orbital implant in its posterior portion in an evisceration animal model. Sixteen New Zealand rabbits were submitted to evisceration of the right eyeball. All animals were implanted with 12 mm diameter of PMMA multiperforated in their posterior hemisphere. The study was divided into clinical and histopathological evaluation. The clinical evaluation was daily during the 14 days after evisceration, and every seven days until completing 180 days. The animals were divided into groups of four animals and each was exenterated at 07, 30, 90 and 180 days and then at euthanasia. Histopathological analysis was aimed at characterizing the inflammatory pattern, the collagen structure and the degree of neovascularization. For this, in addition to the traditional hematoxylin-eosin staining (HE), we used the Picrosirius Red dye (PSR) and immunohistochemistry with the CD34 marker. There were no signs of infection, exposure or extrusion of the implant in any animal during the study. On the seventh day, the newly formed tissue migrated into the implant, forming a fibrovascular network through the posterior channels. The inflammatory response decreased over time and no multinucleated giant cells were found. The implant analyzed is biocompatible, inert and its structure allows its integration into the orbital tissues by fibrovascular growth.

Darbo tikslas – ištirti ir įvertinti anoftalminės akiduobės endoprotezavimo kosmetinio ir funkcinio efekto parametrus ir jų stabilumą intervaliniu dvejų metų stebėjimo laikotarpiu. Darbo uždaviniai 1. Įvertinti ir palyginti endoprotezuotos ir neendoprotezuotos akiduobės poenukleacinio sindromo išraišką ankstyvuoju pooperaciniu laikotarpiu. 2. Įvertinti ir palyginti tirtų ligonių grupių ankstyvojo pooperacinio laikotarpio dirbtinės ir porinės akies statinę simetriją. 3. Nustatyti akiduobės implanto įtaką dirbtinės akies judesiams. 4. Įvertinti ir palyginti abiejų ligonių grupių dirbtinės ir porinės akies dinaminę simetriją ankstyvuoju pooperaciniu laikotarpiu. 5. Įvertinti ir palyginti tirtųjų ligonių grupių kosmetinį ir funkcinį operacijos efektą, praėjus 6 mėn., 12 mėn. ir 24 mėn. po operacijos. 6. Palyginti pooperacinį kosmetinį ir funkcinį efektą, endoprotezavus akiduobę pirminiu ar antriniu būdu bei pašalinus akį skirtingais metodais. 7. Įvertinti operuotų ligonių subjektyvią nuomonę apie kosmetinį akiduobės endoprotezavimo efektą. / The removal of the globe creates anatomic and physiological alterations of orbital tissue and orbital bones. The main problems of anophthalmic socket are its contraction and volume deficit. Because of the latter the so-called postenucleation socket syndrome appears which may be characterized by deep upper lid sulcus, upper lid ptosis enophtalmus of the artificial eye and the lower lid laxity. The average size of the functioning eye is 6-7 cm3. After the removal of an eye it has to be restored. For this purpose the implants are used which are being sewed in the orbit, under the conjunctiva. Attachment of the extraocular muscles to the implant helps to save their function and improves the motility of the artificial eye.The endoimplantation of anophthalmic orbit in Lithuania is not implemented widely enough. Thus, assuming the rapid development of medical technologies it is relevant to evaluate the practical experience of the mentioned treatment method, its close and distal results in order to implement it to clinical practise more widely and successfully as well to improve the life quality of operated people.