Factors affecting perceptual thresholds in epiretinal prostheses.

PURPOSE: The goal was to evaluate how perceptual thresholds are related to electrode impedance, electrode size, the distance of electrodes from the retinal surface, and retinal thickness in six subjects blind as a result of retinitis pigmentosa, who received epiretinal prostheses implanted monocularly as part of a U.S. Food and Drug Administration (FDA)-approved clinical trial. METHODS: The implant consisted of an extraocular unit containing electronics for wireless data, power recovery, and generation of stimulus current, and an intraocular unit containing 16 platinum stimulating electrodes (260- or 520-microm diameter) arranged in a 4 x 4 pattern. The electrode array was held onto the retina by a small tack. Stimulation was controlled by a computer-based external system that allowed independent control over each electrode. Perceptual thresholds (the current necessary to see a percept on 79% of trials) and impedance were measured for each electrode on a biweekly basis. The distance of electrodes from the retinal surface and retinal thickness were measured by optical coherence tomography on a less regular basis. RESULTS: Stimulation thresholds for detecting phosphenes correlated with the distance of the electrodes from the retinal surface, but not with electrode size, electrode impedance, or retinal thickness. CONCLUSIONS: Maintaining close proximity between the electrode array and the retinal surface is critical in developing a successful retinal implant. With the development of chronic electrode arrays that are stable and flush on the retinal surface, it is likely that the influence of other factors such as electrode size, retinal degeneration, and subject age will become more apparent. (ClinicalTrials.gov number, NCT00279500.).

Visual performance using a retinal prosthesis in three subjects with retinitis pigmentosa.

PURPOSE: To assess visual task performance in three blind subjects implanted with epiretinal prostheses. DESIGN: Prospective, investigational device exemption trial. METHODS: Three subjects with light perception or no light perception vision were enrolled at a single center. All subjects had retinitis pigmentosa (RP). Main inclusion criteria: light perception or worse vision in one eye and some visual experience as an adult before blindness. Main exclusion criteria included other ophthalmic problems. A prototype retinal prosthesis was implanted in the eye with worse light sensitivity. The prosthesis had 4 x 4 array of platinum electrodes tacked to the epiretinal surface. The prosthesis was wirelessly controlled by a computer or by a head-worn video camera. Visual function testing was performed in single masked or double masked fashion. Scores from the visual task were compared to chance to determine statistical significance. RESULTS: The subjects performed significantly better than chance in 83% of the tests. Using the video camera, subjects scored as follows on simple visual tasks: locate and count objects (77% to 100%), differentiate three objects (63% to 73%), determine the orientation of a capital L (50% to 77%), and differentiate four directions of a moving object (40% to 90%). A subset of tests compared camera settings using multipixels vs single pixels. Using multipixel settings, subjects performed better (17%) or equivalent (83%) in accuracy and better (25%) or equivalent (75%) in reaction time. CONCLUSIONS: Three RP implant subjects used epiretinal prostheses to perform simple visual tasks. Multipixel settings proved slightly more effective than single pixel settings.

Effect of oxygenated intraocular irrigation solutions on the electroretinogram after vitrectomy.

PURPOSE: To investigate the effect of oxygenated intraocular irrigating solutions on electroretinograms (ERGs) for postvitrectomy rabbits. METHODS: Eight groups of five rabbits each underwent pars plana vitrectomy on the right eye; the left eye of each rabbit served as control. The intraocular irrigating solutions were balanced salt solution (BSS), BSS-plus, BSS + oxygen (BSS + O2), BSS-plus + O2, and combinations of each with the addition of endoillumination (L). All animals were evaluated by single-flash scotopic electroretinography on the operated and nonoperated eyes before surgery and at 1 hour, 1 day, 1 week, and 1 month after surgery by an unmasked observer. The main outcome measures were dark-adapted b-wave amplitudes of operated eye/nonoperated eye ratios. The results for the different groups were compared by analysis of variance. RESULTS: Mean dark-adapted b-wave amplitudes of operated eye/nonoperated eye ratios +/- SD for BSS-plus and BSS-plus + O2 before surgery and 1 hour, 1 day, 1 week, and 1 month after surgery were 1.01 +/- 0.09, 0.50 +/- 0.11, 0.95 +/- 0.11, 0.97 +/- 0.11, and 0.99 +/- 0.08 and 0.98 +/- 0.08, 0.59 +/- 0.10, 0.92 +/- 0.06, 0.97 +/- 0.08, and 0.97 +/- 0.10, respectively. At both 1 hour and 1 day after surgery, rabbits treated with BSS-plus + O2 had an earlier b-wave return to baseline findings, but the differences were not statistically significant (P > 0.05). Mean dark-adapted b-wave amplitudes of operated eye/nonoperated eye ratios +/- SD for BSS and BSS + O2 before surgery and 1 hour, 1 day, 1 week, and 1 month after surgery were 1.02 +/- 0.10, 0.47 +/- 0.09, 0.77 +/- 0.07, 0.89 +/- 0.07, and 0.89 +/- 0.07 and 1.02 +/- 0.06, 0.62 +/- 0.16, 0.94 +/- 0.09, 0.97 +/- 0.08, and 0.96 +/- 0.06, respectively. One hour and 1 day after surgery, ERG readings for rabbits treated with BSS + O2 exhibited a statistically significantly earlier return of ERG voltage to baseline values compared with both BSS and BSS + L (P = 0.05 and P = 0.02, respectively). One day after surgery, rabbits treated with BSS alone had the lowest ERG ratios. One week and 1 month after surgery, for all solutions tested other than BSS, ERG values were within normal limits. CONCLUSION: The use of oxygenated solutions appears to affect ERG readings after pars plana vitrectomy. Further studies to evaluate the role of oxygenated solutions in different vitreoretinal surgical procedures are warranted.

Perceptual thresholds and electrode impedance in three retinal prosthesis subjects.

Three test subjects blind from retinitis pigmentosa were implanted with retinal prostheses as part of a FDA-approved clinical trial. The implant consisted of an extraocular unit that contained electronics for wireless data, power, and generation of stimulus current, and an intraocular unit that consisted of 16 platinum stimulating electrodes arranged in a 4 x 4 pattern within a silicone rubber substrate. The array was held to the retina by a small tack. The stimulator was connected to the array by a multiwire cable and was controlled by a computer based external system that allowed precise control over each electrode. Perception thresholds and electrode impedance were obtained on each electrode from the subjects over several months of testing. The electrode distance from the retina was determined from optical coherence tomography imaging of the array and retina. Across all subjects, average thresholds ranged from 24-702 microA (1-ms pulse). The data show that proximity to the retina played a role in determining the threshold and impedance, but only for electrodes that were greater than 0.5 mm from the retina.

Advances in the development of visual prostheses.

Visual prostheses are based on neuronal electrical stimulation at different locations along the visual pathway (ie, cortical, optic nerve, epiretinal, subretinal). In terms of retinal prostheses, advances in microtechnology have allowed for the development of sophisticated, high-density integrated circuit devices that may be implanted either in the subretinal or epiretinal space. Analogous to the cochlear implants for some forms of deafness, these devices could restore useful vision by converting visual information into patterns of electrical stimulation that would excite the remaining spared inner retinal neurons in patients with diseases such as retinitis pigmentosa and age-related macular degeneration. The different types of implants and recent results are discussed, but special emphasis is given to retinal implants.

The value of preoperative tests in the selection of blind patients for a permanent microelectronic implant.

PURPOSE: To determine the best candidates (ie, those requiring lowest current levels delivered to the retina to elicit visual perceptions) for long-term implantation of a microelectronic retinal implant through a series of preoperative visual, psychophysical, and electrophysiological tests. METHODS: This study protocol was granted an investigational device exemption by the Food and Drug Administration and was approved by the institutional review board at the University of Southern California. After informed consent was obtained, all subjects underwent the following preoperative tests: dark-adapted bright flash and 30-Hz flicker electroretinograms, electrical evoked responses (EERs) using a Burian-Allen corneal electrode to stimulate the globe, and psychophysical tests to evaluate the light and electrically elicited visual perceptions. Intraocular stimulation (IOS) of the retina was performed by an array of electrodes positioned on the internal limiting lamina. RESULTS: Lower vision correlated with less sensitive psychophysical responses (P<.0001). Lower vision and less sensitive psychophysical tests correlated with higher EER values for stimulus pulse widths of 2 ms (P<.0008) and 4 ms (P<.0002). Lower IOS currents correlated with more sensitive psychophysical responses (P<.02) and lower EER values at 4 ms (P<.04). CONCLUSIONS: Preoperative testing, especially psychophysical and electrophysiological tests to assess light and electrically driven visual responses, can help in evaluating patients for suitability for receiving a permanent microelectronic retinal implant. Further study is warranted.

Ressonância magnética na esclerose múltipla: análise de 107 casos / Magnetic resonance imaging in multiple sclerosis: analysis of 107 cases

Os autores apresentam 107 casos de pacientes com história clínica compatível com esclerose múltipla e confirmados pela ressonância magnética. Säo feitas consideraçöes sobre a incidência quanto ao sexo, grupos etários e localizaçäo das lesöes. Por se tratar de doença considerada rara nos países tropicais, os autores tecem consideraçöes didáticas sobre os critérios clínicos e laboratoriais úteis na prática radiológica e alertam os imagenologistas para o significado diagnóstico desta doença no Brasil