Peli Eli
Schepens Eye Research Institute of Mass Eye & Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.
Transl Vis Sci Technol. 2020 Dec 18;9(13):32. doi: 10.1167/tvst.9.13.32. eCollection 2020 Dec.
Visual prostheses aim to restore, at least to some extent, vision that leads to the type of perception available for sighted patients. Their effectiveness is almost always evaluated using clinical tests of vision. Clinical vision tests are designed to measure the limits of parameters of a functioning visual system. I argue here that these tests are rarely suited to determine the ability of prosthetic devices and other therapies to restore vision. This paper describes and explains many limitations of these evaluations. Prosthetic vision testing often makes use of multiple-alternative forced-choice (MAFC) procedures. Although these paradigms are suitable for many studies, they are frequently problematic in vision restoration evaluation. Two main types of problems are identified: (1) where nuisance variables provide spurious cues that can be learned in repeated training, which is common in prosthetic vision, and thus defeat the purpose of the test; and (2) even though a test is properly designed and performed, it may not actually measure what the researchers believe, and thus the interpretation of results is wrong. Examples for both types of problems are presented. Additional problems arise from confounding factors in the administration of tests are pointed as limitations of current device evaluation. For example, head tracing of magnified objects enlarged to compensate for the system's low resolution, in distinction from the scanning head (camera) movements with which users of prosthetic devices expand the limited field of view. Because of these problems, the ability to perform satisfactorily on the clinical tests is necessary but insufficient to prove vision restoration, therefore, additional tests are needed. I propose some directions to pursue in such testing.
Numerous prosthetic devices are being developed and introduced to the market. Proving the utility of these devices is crucial for regulatory and even for post market acceptance, which so far has largely failed, in my opinion. Potential reasons for the failures despite success in regulatory testing and directions for designing improved testing are provided. It is hoped that improved testing will guide improved designs of future prosthetic systems and other vision restoration approaches.
视觉假体旨在至少在一定程度上恢复视力,使患者能够获得类似于有视力者的感知类型。其有效性几乎总是通过视力临床测试来评估。临床视力测试旨在测量正常运作的视觉系统参数的极限。我在此认为,这些测试很少适合于确定假体装置和其他疗法恢复视力的能力。本文描述并解释了这些评估的许多局限性。假体视力测试通常采用多项选择强迫选择(MAFC)程序。虽然这些范式适用于许多研究,但在视力恢复评估中经常出现问题。确定了两种主要类型的问题:(1)干扰变量提供了在重复训练中可以学习的虚假线索,这在假体视力中很常见,从而破坏了测试的目的;(2)即使测试设计和执行得当,它可能实际上并未测量研究人员所认为的内容,因此结果的解释是错误的。文中给出了这两种类型问题的示例。测试管理中的混杂因素还引发了其他问题,这些问题被指出是当前设备评估的局限性。例如,放大物体的头部追踪以补偿系统的低分辨率,这与假体装置使用者为扩大有限视野而进行的扫描头部(摄像头)移动不同。由于这些问题,在临床测试中表现令人满意是证明视力恢复的必要条件,但并不充分,因此还需要额外的测试。我提出了此类测试可遵循的一些方向。
众多假体装置正在研发并推向市场。证明这些装置的效用对于监管乃至市场后接受度都至关重要,而在我看来,目前市场后接受度在很大程度上是失败的。文中提供了尽管在监管测试中取得成功但仍失败的潜在原因以及设计改进测试的方向。希望改进后的测试将指导未来假体系统和其他视力恢复方法的改进设计。