Novo dispositivo para correção da afacia sem suporte capsular: prova de conceito

• Autor(a) principal: Bergamasco, Victor Dias [UNIFESP]
• Data de Publicação: 2020
• Tipo de documento: Tese
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• Texto Completo: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=10073539; https://hdl.handle.net/11600/64871
• topic: Aphakia; Cataract; Intraocular Lens; Prototyping; Afácia; Catarata; Lente Intraocular; Prototipagem

Introduction: According to the World Health Organization (WHO), cataract is a leading cause of visual impairment (best corrected visual acuity under 20/60) worldwide. Facectomy is one of the most performed surgeries in modern society. More than 30 million patients will go through cataract extraction in 2020. Even though it is a safe and predictable procedure still some complications may occur, for example the loss of capsular support resulting in impossibility to perform intraocular lens implant and aphakia. In those cases, other ocular tissues are used to support the lens in the absence of capsular bag support and many techniques have been described in the literature. The present techniques have several unmet needs; are technically difficult for most surgeons, require special lens and surgical instruments, multiple incisions and sutures, lead to intense inflammatory response and to short and long-term intraocular pressure disorders and IOL displacement and tilt. The ideal solution should be technically easy and accessible with no need of special lens or surgical instruments, minimally invasive and predictable and stable IOL positioning. Purposes: To develop a prototype device for aphakia without capsular bag support resolution. To describe the development methodology. To evaluate the prototyping technologies used. To evaluate the prototype clinical effectiveness through a proof of concept. Methods: For this technology development project a development cycle was created and applied. The cycle consisted in idealization, prototyping, evaluation and improvements proposition. Using this development cycle nine prototype versions were created and evaluated for the most relevant aspects for the concept. The evaluation consisted in grading each relevant aspect of each prototype version. To determine the best prototype the scores for each aspect of each version were added and resulted in a final score per prototype. The highest prototype score was considered the best prototype. Results: Nine prototypes were idealized and created. Versions V1P to V7P were developed for cadaveric porcine eyes testing. Versions V8H and V9H were tested in human cadaveric eyes. A simplified implant technic was developed and the version V9H had the highest score and was considered the most satisfactory for the evaluated aspects. Conclusions: It was possible to develop a prototype device for aphakia without capsular bag support resolution as well as to describe the development methodology. It was possible to successfully evaluate the prototyping technologies used and identify that the 3D printing technology was the best option available Although most of the aspects were successfully addressed in the best evaluated version, IOL positioning and stability remains unsatisfactory.