N/A
N=6
The Perceptual Experience of Argus II Users
Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT05285618 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number of Phosphenes Perceived — 1.09; 1.43; 1.46; 1.41 number of phosphenes — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Argus II (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Santa Barbara
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Phosphenes Perceived |
1.09; 1.43; 1.46; 1.41; 1.48; 1.37 | 0.002 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT05285618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.