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临床试验/NCT05285618
NCT05285618已完成不适用

Predicting the Perceptual Experience of Argus II Retinal Prosthesis System Users

University of California, Santa Barbara6 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
6
主要终点
Number of Phosphenes Perceived

研究概览

简要总结

This Basic Experimental Studies Involving Humans (BESH) study investigates phosphene perception and performance factors in blind participants implanted with the Argus II retinal prosthesis system. Using paired-electrode stimulation, we analyze how phosphene shape and number are influenced by neuroanatomical factors, stimulus parameters, and spatial offsets. Additionally, we examine the causes of high current thresholds and limited spatial resolution, which impede pattern vision in Argus II devices. This research aims to provide insights for optimizing stimulation strategies and improving retinal prosthesis design.

详细描述

This study focuses on two experiments involving blind participants implanted with the Argus II retinal prosthesis:

Experiment 1: Paired-Electrode Phosphene Perception The study retrospectively analyzes 3548 phosphene drawings made by three participants. We investigate the impact of single- and paired-electrode stimulation on phosphene shape (area, perimeter, major/minor axis length) and the number of perceived phosphenes. Neuroanatomical parameters, including electrode-retina distance, electrode-fovea distance, and electrode-electrode distance (both along-axon and between-axon), are correlated with these outcomes. Statistical analyses include linear regression and partial correlation to examine the relationship between stimulation parameters and phosphene perception.

Experiment 2: Performance Factors in Argus II Prostheses This study explores the factors contributing to high current amplitude thresholds and poor spatial resolution in three participants. We measure current amplitude thresholds and two-point discrimination (the ability to distinguish stimulation on one versus two electrodes). Data from psychophysical experiments and simulations are analyzed to identify the roles of axonal stimulation, electrode lift, and retinal damage in limiting device performance.

These experiments aim to advance the understanding of epiretinal stimulation and inform the development of future retinal prostheses with improved spatial resolution and sensitivity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Phosphenes Perceived

时间窗: during single-session testing

Number of phosphenes perceived in response to paired-electrode stimulation across 5 spatial distances and 7 temporal interpulse delays. Phosphenes are brief sensations of light or visual flashes that occur in the absence of an external light source. A response is counted as a phosphene if the participant reports any visual sensation consistent with a flash of light.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Beyeler, PhD

Professor

University of California, Santa Barbara

研究点 (6)

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