The functional performance of the Argus II retinal prosthesis.
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ABSTRACT:
SUBMITTER: Stronks HC
PROVIDER: S-EPMC3926652 | biostudies-literature | 2014 Jan
REPOSITORIES: biostudies-literature
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The functional performance of the Argus II retinal prosthesis.
Stronks H Christiaan HC Dagnelie Gislin G
Expert review of medical devices 20131122 1
Visual prostheses are devices to treat profound vision loss by stimulating nerve cells anywhere along the visual pathway, typically with electrical pulses. The Argus II implant, developed by Second Sight Medical Products (SSMP, Sylmar, CA, USA), targets the retina and features 60 electrodes that electrically stimulate the surviving retinal neurons. Of the approximately 20 research groups that are actively developing visual prostheses, SSMP has the longest track record. The Argus II was the first ...[more]
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Project description:PurposeA 59-year-old man with retinitis pigmentosa, who received an Argus II retinal prosthesis in the left eye 3 years prior, presented with left-sided involuntary facial contractions that occurred only after turning on the Argus II device.MethodsA case report.ResultsGiven that this patient's reported and visualized lower eyelid twitching corresponds to the location of the external region of the implanted coil, we hypothesize that heat or wirelessly transmitted electrical signals from the external coil to the implanted coil may induce spasm of the facial nerve and thus play a role in hemifacial spasm onset.ConclusionsTo our knowledge, this is the first report of hemifacial spasm associated with Argus II use.
| S-EPMC9976104 | biostudies-literature
Project description:ImportanceThe Argus II Retinal Prosthesis System is indicated for patients with vision loss due to severe to profound outer retinal degeneration, a group with few treatment options.ObjectivesTo collect postapproval safety and visual function data for the Argus II.Design, setting, and participantsMulticenter, postapproval clinical trial conducted at 9 sites in Germany and Italy. Data were collected from December 2, 2011, to September 30, 2017, and patients were followed-up for 12 months or longer. Patients were 25 years or older with severe to profound outer retinal degeneration, some residual light perception or the ability of the retina to respond to electrical stimulation, and a history of useful form vision and were already planning to undergo Argus II implantation.Main outcomes and measuresThe primary end point of this study was the nature and rate of adverse events. Secondary end points included 3 visual function tests: square localization (SL), direction of motion, and grating visual acuity (GVA).ResultsForty-seven patients were followed for 12 months or longer after implant. Mean (SD) age was 56 (12) years, 37 (79%) had retinitis pigmentosa, and 27 (57%) were male. Through the first 12 months postimplantation, 23 patients (49%) experienced 51 nonserious adverse events and 12 (26%) experienced 13 serious adverse events (SAEs), 9 of which were judged to be related to the Argus II, and 4 of which were judged to be related to the procedure. The most common SAE was conjunctival erosion, reported in 4 patients. No significance testing was done for group analysis for the SL or direction-of-motion tests. When averaged across the group, patients' accuracy on the SL test, but not on the direction-of-motion test, appeared better when the Argus II was on than when it was switched off. For GVA, more patients at each point in time achieved the 2.9 GVA cutoff in the implanted eye when the Argus II was on compared with it switched off.Conclusions and relevanceSafety and visual function outcomes in this clinical practice setting cohort of patients with Argus II implants were consistent with previously reported results. Longer follow-up of these patients and data from additional patients are required to better outline the risks and benefits of this approach to addressing blindness secondary to severe-to-profound outer retinal degeneration.Trial registrationClinicalTrials.gov identifier: NCT01490827.
| S-EPMC6547244 | biostudies-literature
Project description:PurposeThe Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.DesignProspective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II.ParticipantsThirty participants in 10 centers in the United States and Europe.MethodsThe worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina.Main outcome measuresThe primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks.ResultsTwenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks.ConclusionsThe 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
| S-EPMC5035591 | biostudies-literature
Project description:PURPOSE:The Argus II epiretinal prosthesis has been developed to provide partial restoration of vision to subjects blinded from outer retinal degenerative disease. Participants were surgically implanted with the system in the United States and Europe in a single arm, prospective, multicenter clinical trial. The purpose of this investigation was to determine which factors affect electrical thresholds in order to inform surgical placement of the device. METHODS:Electrode-retina and electrode-fovea distances were determined using SD-OCT and fundus photography, respectively. Perceptual threshold to electrical stimulation of electrodes was measured using custom developed software, in which current amplitude was varied until the threshold was found. Full field stimulus light threshold was measured using the Espion D-FST test. Relationships between electrical threshold and these three explanatory variables (electrode-retina distance, electrode-fovea distance, and monocular light threshold) were quantified using regression. RESULTS:Regression analysis showed a significant correlation between electrical threshold and electrode-retina distance (R2 = 0.50, P = 0.0002; n = 703 electrodes). 90.3% of electrodes in contact with the macula (n = 207) elicited percepts at charge densities less than 1 mC/cm2/phase. These threshold data also correlated well with ganglion cell density profile (P = 0.03). A weaker, but still significant, inverse correlation was found between light threshold and electrical threshold (R2 < 0.52, P = 0.01). Multivariate modeling indicated that electrode-retina distance and light threshold are highly predictive of electrode threshold (R2 = 0.87; P < 0.0005). CONCLUSIONS:Taken together, these results suggest that while light threshold should be used to inform patient selection, macular contact of the array is paramount. TRANSLATIONAL RELEVANCE:Reported Argus II clinical study results are in good agreement with prior in vitro and in vivo studies, and support the development of higher-density systems that employ smaller diameter electrodes. (clinicaltrials.gov identifier: NCT00407602).
| S-EPMC3763895 | biostudies-literature
Project description:BackgroundThe main objective of this study was to test Argus II subjects on three real-world functional vision tasks.DesignThe study was designed to be randomized and prospective. Testing was conducted in a hospital/research laboratory setting at the various participating centres.ParticipantsTwenty eight Argus II subjects, all profoundly blind, participated in this study.MethodsSubjects were tested on the three real-world functional vision tasks: Sock Sorting, Sidewalk Tracking and Walking Direction Discrimination task MAIN OUTCOME MEASURES: For the Sock Sorting task, percentage correct was computed based on how accurately subjects sorted the piles on a cloth-covered table and on a bare table. In the Sidewalk Tracking task, an 'out of bounds' count was recorded, signifying how often the subject veered away from the test course. During the Walking Direction Discrimination task, subjects were tested on the number of times they correctly identified the direction of testers walking across their field of view.ResultsThe mean percentage correct OFF versus ON for the Sock Sorting task was found to be significantly different for both testing conditions (t-test, P < 0.01). On the Sidewalk Tracking task, subjects performed significantly better with the system ON than they did with the system OFF (t-test, P < 0.05). Eighteen (18) of 27 subjects (67%) performed above chance with the system ON, and 6 (22%) did so with system OFF on the Walking Direction Discrimination task.ConclusionsArgus II subjects performed better on all three tasks with their systems ON than they did with their systems OFF.
| S-EPMC5293683 | biostudies-literature
Project description:Retinal prosthesis technologies require that the visual system downstream of the retinal circuitry be capable of transmitting and elaborating visual signals. We studied the capability of plastic remodeling in late blind subjects implanted with the Argus II Retinal Prosthesis with psychophysics and functional MRI (fMRI). After surgery, six out of seven retinitis pigmentosa (RP) blind subjects were able to detect high-contrast stimuli using the prosthetic implant. However, direction discrimination to contrast modulated stimuli remained at chance level in all of them. No subject showed any improvement of contrast sensitivity in either eye when not using the Argus II. Before the implant, the Blood Oxygenation Level Dependent (BOLD) activity in V1 and the lateral geniculate nucleus (LGN) was very weak or absent. Surprisingly, after prolonged use of Argus II, BOLD responses to visual input were enhanced. This is, to our knowledge, the first study tracking the neural changes of visual areas in patients after retinal implant, revealing a capacity to respond to restored visual input even after years of deprivation.
| S-EPMC5079588 | biostudies-literature
Project description:BackgroundThe Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, California) is an epiretinal prosthesis that serves to provide useful vision to people who are affected by retinal degenerative diseases such as retinitis pigmentosa (RP). The purpose of this study was to analyze postoperative movement of the electrode array.MethodsFive patients diagnosed with profound retinal dystrophy who have undergone implantation of retinal prosthesis at Stony Brook University Hospital. Fundoscopy was performed at postoperative month 1 (M1), month 3 (M3), month 6 (M6), month 12 (M12), and month 24 (M24) visits. Fundoscopy was extracted and analyzed via NIH ImageJ. Data analysis was completed using IBM SPSS. Various lengths and angles were measured each postoperative month using ImageJ.ResultsThere was no significant change in distance between the optic disc and the surgical handle (length AB) over the two-year span (F = 0.196, p = 0.705). There was a significant change in distance of length AB over time between patients between M3 and M6 (p = 0.025). A repeated measures ANOVA revealed that there was statistically significant change of the optic disc-tack-surgical handle angle (𝛾) (M1 to M24) (F = 3.527, p = 0.030). There was no significant change in angle 𝜟 (the angle to the horizontal of the image), angle 𝜶 (tack-optic disc-surgical handle), and angle 𝜷 (optic-disc-surgical handle-tack).ConclusionOur results demonstrate that there may be postoperative movement of the retinal prosthesis over time, as a statistically significant downward rotation is reported over the 2 years span. It is important, moving forward, to further study this movement and to take into consideration such movement when designing retinal implants. It is important to note that this study is limited by the small sample size, and therefore, the conclusions drawn are limited.
| S-EPMC9933348 | biostudies-literature
Project description:Crossmodal mappings associate features (such as spatial location) between audition and vision, thereby aiding sensory binding and perceptual accuracy. Previously, it has been unclear whether patients with artificial vision will develop crossmodal mappings despite the low spatial and temporal resolution of their visual perception (particularly in light of the remodeling of the retina and visual cortex that takes place during decades of vision loss). To address this question, we studied crossmodal mappings psychophysically in Retinitis Pigmentosa patients with partial visual restoration by means of Argus II retinal prostheses, which incorporate an electrode array implanted on the retinal surface that stimulates still-viable ganglion cells with a video stream from a head-mounted camera. We found that Argus II patients (N = 10) exhibit significant crossmodal mappings between auditory location and visual location, and between auditory pitch and visual elevation, equivalent to those of age-matched sighted controls (N = 10). Furthermore, Argus II patients (N = 6) were able to use crossmodal mappings to locate a visual target more quickly with auditory cueing than without. Overall, restored artificial vision was shown to interact with audition via crossmodal mappings, which implies that the reorganization during blindness and the limitations of artificial vision did not prevent the relearning of crossmodal mappings. In particular, cueing based on crossmodal mappings was shown to improve visual search with a retinal prosthesis. This result represents a key first step toward leveraging crossmodal interactions for improved patient visual functionality.
| S-EPMC7987772 | biostudies-literature
Project description:Over the past few years, visual prostheses (namely, Argus II retinal implant) and gene therapy have obtained FDA approval in treating blindness resulting from retinitis pigmentosa. Compared to gene therapy; Argus II is less costly with a demonstrated favorable outcome, though the vision is yet artificial. To obtain better results, expectation counseling and preoperative retinal assessment are critical. The global experience with Argus II has enrolled no more than 300 cases so far. The first Argus II retinal prosthesis in Iran was successfully implanted in Shiraz (October 2017). To date, Argus II artificial retina is implanted in four patients in Iran. Beside successful surgery and post-operative care, rehabilitation efforts with validated outcome measures including visual rehabilitation together with neurovisual, visuo-constructive and cognitive rehabilitation/empowerment approaches are expected to boost the functional outcome. A multidisciplinary approach within a cross-functional team would optimize strategies toward better patient outcomes. As such, establishing a collaborative network will foster organized research efforts to better define outcome assessment and rehabilitation strategies. This technology report paper has been an attempt to provide an overview of Argus-II retinal implant global experience as well as the clinical outcome of the so far cases in Iran. Insights from this report were communicated during the first "Brain Engineering and Computational Neuroscience Conference," 31 January-2 February 2018 in Tehran.
| S-EPMC6136639 | biostudies-literature
Project description:PurposeMagnetic resonance imaging (MRI) can measure the effects of vision loss and recovery on brain function and structure. In this case study, we sought to determine the feasibility of acquiring anatomical and functional MRI data in recipients of the Argus II epiretinal prosthesis system.MethodsFollowing successful implantation with the Argus II device, two retinitis pigmentosa (RP) patients completed MRI scans with their implant unpowered to measure primary visual cortex (V1) functional responses to a tactile task, whole-brain morphometry, V1 cortical thickness, and diffusion properties of the optic tract and optic radiation. Measurements in the subjects with the Argus II implant were compared to measurements obtained previously from RP patients and sighted individuals.ResultsThe presence of the Argus II implant resulted in artifacts that were localized around the patient's implanted eye and did not extend into cortical regions or white matter tracts associated with the visual system. Structural data on V1 cortical thickness and the retinofugal tract obtained from the two Argus II subjects fell within the ranges of sighted and RP groups. When compared to the RP and sighted subjects, Argus II patients' tactile-evoked cross-modal functional MRI (fMRI) blood oxygen level-dependent (BOLD) responses in V1 also fell within the range of either sighted or RP groups, apparently depending on time since implantation.ConclusionsThis study demonstrates that successful acquisition and quantification of structural and functional MR images are feasible in the presence of the inactive implant and provides preliminary information on functional changes in the brain that may follow sight restoration treatments.Transitional relevanceSuccessful MRI and fMRI acquisition in Argus II recipients demonstrates feasibility of using MRI to study the effect of retinal prosthesis use on brain structure and function.
| S-EPMC4675319 | biostudies-literature