Xia Yu, Ren Qiushi
Department of Biomedical Engineering, School of Life Science and Technology, Shanghai Jiao Tong University, Shanghai, China.
Int J Artif Organs. 2010 Dec;33(12):844-50.
With the development of retinal prostheses, the first clinical trials for these devices are being planned or are already underway. Yet the candidate selection criteria and the preparation of early recipients have received very little attention. As clinical trials grow in scope, the need for such issues will become increasingly important. Especially in preliminary stages of clinical trials, it is absolutely vital to develop the preoperative evaluations of candidates in identifying the suitable candidate for retinal prosthesis implants. This paper addresses the preoperative evaluations of candidates that may provide insight into selecting potential candidates for retinal prosthetic devices. Screening an ideal candidate is complex and, at the minimum, should include medical evaluations, visual function tests, assessments of psychological status, motivation, expectations, as well as rehabilitation capabilities. This will ensure that appropriate candidates are selected, candidate expectations are managed, and success with the retinal prosthetic devices is maximized.
随着视网膜假体的发展，这些设备的首次临床试验正在规划中或已经在进行。然而，候选者的选择标准和早期接受者的准备工作却很少受到关注。随着临床试验规模的扩大，解决此类问题的需求将变得越来越重要。特别是在临床试验的初步阶段，开展术前对候选者的评估以确定适合视网膜假体植入的候选者绝对至关重要。本文论述了对候选者的术前评估，这可能有助于为选择视网膜假体设备的潜在候选者提供见解。筛选理想的候选者是复杂的，至少应包括医学评估、视觉功能测试、心理状态评估、动机、期望以及康复能力评估。这将确保选择合适的候选者，管理候选者的期望，并使视网膜假体设备的成功率最大化。
