Clinical trial NCT05285618: The Perceptual Experience of Argus II Users
Official title: Predicting the Perceptual Experience of Argus II Retinal Prosthesis System Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: University of California, Santa Barbara
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Michigan
name: National Eye Institute (NEI)
First posted: 2022-03-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* Subject must be at least 25 years of age;
* Subject has been implanted with the Argus II system;
* Subject's eye has healed from surgery and the surgeon has cleared the subject for programming;
* Subject has the cognitive and communication ability to participate in the study (i.e., follow spoken directions, perform tests, and give feedback);
* Subject is willing to conduct psychophysics testing up to 4-6 hours per day of testing on 3-5 consecutive days;
* Subject is capable of understanding patient information materials and giving written informed consent;
* Subject is able to walk unassisted.

Exclusion criteria:

* Subject is unwilling or unable to travel to testing facility for at least 3 days of testing within a one-week timeframe;
* Sighted controls: Subject has a history of motion sickness or flicker vertigo
* Subject does not speak English;
* Subject has language or hearing impairment

Primary outcomes:
measure: Number of Phosphenes Perceived
timeFrame: during single-session testing
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: University of California, Santa Barbara
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan, Ann Arbor
state: Michigan
Study officials:
affiliation: University of California, Santa Barbara
name: Michael Beyeler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yucel EI, Sadeghi R, Kartha A, Montezuma SR, Dagnelie G, Rokem A, Boynton GM, Fine I, Beyeler M. Factors affecting two-point discrimination in Argus II patients. Front Neurosci. 2022 Aug 24;16:901337. doi: 10.3389/fnins.2022.901337. eCollection 2022.
citation: Hou Y, Nanduri D, Granley J, Weiland JD, Beyeler M. Axonal stimulation affects the linear summation of single-point perception in three Argus II users. J Neural Eng. 2024 Apr 8;21(2):026031. doi: 10.1088/1741-2552/ad31c4.