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  1. Book ; Online: Implanting the Argus(R) II Retinal Prosthesis System in a patient with dry AMD

    Stanga, Paulo Eduardo / Huang, Suber / Merlini, Francesco

    2016  

    Abstract: The following is an edited movie of a previously live-streamed surgical video featuring renowned Consultant Ophthalmologist and Vitreoretinal surgeon Professor Paulo E. Stanga, MD, implanting the Argus® II Retinal Prosthesis System in a patient with dry ... ...

    Institution eyeMoviePedia gGmbH
    Author's details eyeMoviePedia ; surgeon: Professor Paulo Stanga ; commentary by: Dr. Suber Huang and Francesco Merlini ; Second Sight, Central Manchester University Hospitals (NHS), Manchester Vision Regeneration Lab, NIHR/Wellcome Trust, MREH200
    Abstract The following is an edited movie of a previously live-streamed surgical video featuring renowned Consultant Ophthalmologist and Vitreoretinal surgeon Professor Paulo E. Stanga, MD, implanting the Argus® II Retinal Prosthesis System in a patient with dry Age Related Macular Degeneration (AMD). To date, June 2016, over 180 Argus® II devices have been implanted worldwide, and are used routinely in advanced Retinitis Pigmentosa patients. This video, recorded at Manchester Royal Eye Hospital, UK, in April 2016, shows Prof. Stanga performing the procedure on a dry AMD patient as part of an investigational study of the Argus® II system in dry AMD (clinicaltrials.gov #NCT02227498 (https://urldefense.proofpoint.com/v2/url?u=http-3A__clinicaltrials.gov_&d=BQMFaQ&c=bMxC-A1upgdsx4J2OmDkk2Eep4PyO1BA6pjHrrW-ii0&r=7eyJJ8AWeg0LAg2jsrUotjxJxMXx-Ph-SVfpXeotLmg&m=gd8KSZ2q-0EknjXm4AycD2Fus7vBLej2uxBB1IdPpXo&s=WwGP-DH6EXzK_4VV6UBiNh0OQf6B571LE559LnerqVQ&e=), being conducted under an approval from MHRA and the Ethics Committee at Manchester Royal Eye Hospital). The trial patients are the first in history to combine artificial vision provided by the Argus® II with their remaining natural peripheral sight. The surgery is commentated by Dr. Suber Huang, of University Hospitals Case Medical Center, Cleveland, Ohio and Francesco Merlini of Second Sight Medical Products Inc.
    Keywords Vitreo-Retina ; Surgical Techniques ; Retina Implant
    Subject code 610
    Language English
    Size 1 Online-Ressource (Länge: 01:14:06)
    Publisher eyeMoviePedia
    Publishing place Köln
    Publishing country Germany
    Document type Book ; Online
    Note Creative Commons Namensnennung-Keine Bearbeitung 3.0 Deutschland Lizenz (https://creativecommons.org/licenses/by-nd/3.0/de/) ; Open Access
    HBZ-ID HT020683147
    DOI 10.3207/2715920703
    Database Repository for Life Sciences

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  2. Article ; Online: Electronic retinal prosthesis for severe loss of vision in geographic atrophy in age-related macular degeneration: First-in-human use.

    Stanga, Paulo E / Tsamis, Emmanouil / Siso-Fuertes, Irene / Dorn, Jessy D / Merlini, Francesco / Fisher, Andy / Crawford, Fiona Ij / Kasbia, Shakti S / Papayannis, Alessandro / Baseler, Heidi A / Morland, Antony B / Hanson, Rachel L / Humayun, Mark / Greenberg, Robert J

    European journal of ophthalmology

    2021  Volume 31, Issue 3, Page(s) 920–931

    Abstract: Background: To date there are yet no available approved therapies for Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).: Methods: Single site, non-randomized safety and efficacy study presenting the preliminary results in a ...

    Abstract Background: To date there are yet no available approved therapies for Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).
    Methods: Single site, non-randomized safety and efficacy study presenting the preliminary results in a cohort of five late stage AMD (GA) patients successfully implanted with the Argus II Retinal Prosthesis System (Second Sight Medical Products Inc., Sylmar, CA, USA). Extensive fundus imaging including retinal photographs from which the GA area was measured. A combination of custom and traditional tests designed for very low vision subjects assessed visual function in study subjects. A Functional Low-Vision Observer Rated Assessment was carried out to evaluate the impact of the system on the subject's daily life. In addition, a study to evaluate structural characteristics of the visual cortex of the brain was performed in one subject using magnetic resonance imaging.
    Results: Seven device-related adverse events were reported, four of which were classed as serious adverse events. Retinal detachment was reported in three patients and was successfully treated within 12 months of onset. Testing showed an improvement in visual function in three of five patients with the system turned on. Magnetic resonance imaging assessed in one patient after implantation indicates a selective increase in cortical myelin and thickness in visual brain regions 1 year post implantation.
    Conclusions: Epiretinal prostheses can successfully be implanted in those affected by GA secondary to late-stage AMD and can elicit visual percepts by electrical stimulation of residual neuroretinal elements and improve basic visual function in those affected.
    MeSH term(s) Electronics ; Geographic Atrophy/diagnosis ; Geographic Atrophy/etiology ; Humans ; Macular Degeneration/complications ; Vision, Low ; Visual Prosthesis
    Language English
    Publishing date 2021-03-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1089461-5
    ISSN 1724-6016 ; 1120-6721
    ISSN (online) 1724-6016
    ISSN 1120-6721
    DOI 10.1177/11206721211000680
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  3. Article ; Online: Total shoulder arthroplasty: downward inclination of the glenoid component to balance supraspinatus deficiency.

    Terrier, Alexandre / Merlini, Francesco / Pioletti, Dominique P / Farron, Alain

    Journal of shoulder and elbow surgery

    2009  Volume 18, Issue 3, Page(s) 360–365

    Abstract: Hypothesis: Supraspinatus deficiency associated with total shoulder arthroplasty (TSA) provokes eccentric loading and may induce loosening of the glenoid component. A downward inclination of the glenoid component has been proposed to balance ... ...

    Abstract Hypothesis: Supraspinatus deficiency associated with total shoulder arthroplasty (TSA) provokes eccentric loading and may induce loosening of the glenoid component. A downward inclination of the glenoid component has been proposed to balance supraspinatus deficiency.
    Methods: This hypothesis was assessed by a numeric musculoskeletal model of the glenohumeral joint during active abduction. Three cases were compared: TSA with normal muscular function, TSA with supraspinatus deficiency, and TSA with supraspinatus deficiency and downward inclination of the glenoid.
    Results: Supraspinatus deficiency increased humeral migration and eccentric loading. A downward inclination of the glenoid partly balanced the loss of stability, but this potential advantage was counterbalanced by an important stress increase within the glenoid cement. The additional subchondral bone reaming required to incline the glenoid component indeed reduced the bone support, increasing cement deformation and stress.
    Conclusion: Glenoid inclination should not be obtained at the expense of subchondral bone support.
    MeSH term(s) Arthroplasty, Replacement/adverse effects ; Arthroplasty, Replacement/methods ; Biomechanical Phenomena ; Computer Simulation ; Finite Element Analysis ; Humans ; Joint Instability/physiopathology ; Joint Instability/prevention & control ; Joint Prosthesis ; Models, Anatomic ; Muscle Contraction/physiology ; Muscle, Skeletal/physiology ; Prosthesis Design ; Prosthesis Failure ; Range of Motion, Articular/physiology ; Sensitivity and Specificity ; Shoulder Joint/physiopathology ; Shoulder Joint/surgery ; Stress, Mechanical
    Language English
    Publishing date 2009-05
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1170782-3
    ISSN 1532-6500 ; 1058-2746
    ISSN (online) 1532-6500
    ISSN 1058-2746
    DOI 10.1016/j.jse.2008.11.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Biomechanical consequences of humeral component malpositioning after anatomical total shoulder arthroplasty.

    Terrier, Alexandre / Ramondetti, Silvio / Merlini, Francesco / Pioletti, Dominique D / Farron, Alain

    Journal of shoulder and elbow surgery

    2010  Volume 19, Issue 8, Page(s) 1184–1190

    Abstract: Hypothesis: We hypothesized that the malpositioning of the humeral component can preclude the long-term success of anatomical total shoulder arthroplasty. The goal of this study was to evaluate the mechanical consequences of superior and inferior ... ...

    Abstract Hypothesis: We hypothesized that the malpositioning of the humeral component can preclude the long-term success of anatomical total shoulder arthroplasty. The goal of this study was to evaluate the mechanical consequences of superior and inferior malpositioning of the humeral head.
    Materials and methods: A numerical musculoskeletal model of the shoulder joint allowing natural humeral head translation was used to simulate a loaded abduction movement controlled by muscular activation. An inferior and superior malpositioning of 5 mm were compared to an optimal positioning. Impingements, articular contact pattern, and cement stress were evaluated.
    Results: Inferior malpositioning of the humeral head induced impingement and limited the abduction level, while superior malpositioning increased the subluxation risk. Both inferior and superior malpositioning increased the stress level within the cement mantle.
    Discussion: This numerical study highlights the importance of an anatomical reconstruction of the glenohumeral surfaces for the success rate of anatomical total shoulder arthroplasty.
    MeSH term(s) Arthroplasty, Replacement/methods ; Biomechanical Phenomena ; Humans ; Humeral Head ; Models, Anatomic ; Shoulder Joint/surgery ; Stress, Mechanical
    Language English
    Publishing date 2010-12
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1170782-3
    ISSN 1532-6500 ; 1058-2746
    ISSN (online) 1532-6500
    ISSN 1058-2746
    DOI 10.1016/j.jse.2010.06.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Conference proceedings: Argus II users’ maximum visual acuity enhancement via the Acuboost™

    Sahel, José-Alain / Merlini, Francesco / Mohand-Said, Saddek / Stanga, Paulo / Caspi, Avi / Greenberg, Robert J. / Cosendai, Grégoire

    2013  , Page(s) WK 5a.18

    Event/congress 26. Internationaler Kongress der Deutschen Ophthalmochirurgen; Nürnberg; 2013
    Keywords Medizin, Gesundheit
    Publishing date 2013-10-18
    Publisher German Medical Science GMS Publishing House; Düsseldorf
    Document type Conference proceedings
    DOI 10.3205/13doc161
    Database German Medical Science

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  6. Conference proceedings: Detection of human faces by blind patients implanted with the Argus® II Retinal Prosthesis System (I)

    Stanga, Paulo / Merlini, Francesco / Sahel, José-Alain / Mohand-Said, Saddek / da Cruz, Lyndon / Caspi, Avi / Greenberg, Robert J.

    2013  , Page(s) WK 5a.21

    Event/congress 26. Internationaler Kongress der Deutschen Ophthalmochirurgen; Nürnberg; 2013
    Keywords Medizin, Gesundheit
    Publishing date 2013-10-18
    Publisher German Medical Science GMS Publishing House; Düsseldorf
    Document type Conference proceedings
    DOI 10.3205/13doc164
    Database German Medical Science

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  7. Article: 3D strain map of axially loaded mouse tibia: a numerical analysis validated by experimental measurements.

    Stadelmann, Vincent A / Hocke, Jean / Verhelle, Jensen / Forster, Vincent / Merlini, Francesco / Terrier, Alexandre / Pioletti, Dominique P

    Computer methods in biomechanics and biomedical engineering

    2009  Volume 12, Issue 1, Page(s) 95–100

    Abstract: A combined experimental/numerical study was performed to calculate the 3D octahedral shear strain map in a mouse tibia loaded axially. This study is motivated by the fact that the bone remodelling analysis, in this in vivo mouse model should be performed ...

    Abstract A combined experimental/numerical study was performed to calculate the 3D octahedral shear strain map in a mouse tibia loaded axially. This study is motivated by the fact that the bone remodelling analysis, in this in vivo mouse model should be performed at the zone of highest mechanical stimulus to maximise the measured effects. Accordingly, it is proposed that quantification of bone remodelling should be performed at the tibial crest and at the distal diaphysis. The numerical model could also be used to furnish a more subtle analysis as a precise correlation between local strain and local biological response can be obtained with the experimentally validated numerical model.
    MeSH term(s) Animals ; Bone Remodeling/physiology ; Compressive Strength/physiology ; Computer Simulation ; Elastic Modulus/physiology ; Imaging, Three-Dimensional/methods ; Male ; Mice ; Mice, Inbred C57BL ; Models, Biological ; Shear Strength ; Stress, Mechanical ; Tibia/physiology ; Weight-Bearing/physiology
    Language English
    Publishing date 2009-02
    Publishing country England
    Document type Evaluation Studies ; Journal Article ; Research Support, Non-U.S. Gov't ; Validation Studies
    ZDB-ID 2071764-7
    ISSN 1025-5842
    ISSN 1025-5842
    DOI 10.1080/10255840903077287
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  8. Article ; Online: The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss.

    da Cruz, Lyndon / Coley, Brian F / Dorn, Jessy / Merlini, Francesco / Filley, Eugene / Christopher, Punita / Chen, Fred K / Wuyyuru, Varalakshmi / Sahel, Jose / Stanga, Paulo / Humayun, Mark / Greenberg, Robert J / Dagnelie, Gislin

    The British journal of ophthalmology

    2013  Volume 97, Issue 5, Page(s) 632–636

    Abstract: Background: Retinal prosthesis systems (RPS) are a novel treatment for profound vision loss in outer retinal dystrophies. Ideal prostheses would offer stable, long-term retinal stimulation and reproducible spatial resolution in a portable form ... ...

    Abstract Background: Retinal prosthesis systems (RPS) are a novel treatment for profound vision loss in outer retinal dystrophies. Ideal prostheses would offer stable, long-term retinal stimulation and reproducible spatial resolution in a portable form appropriate for daily life.
    Methods: We report a prospective, internally controlled, multicentre trial of the Argus II system. Twenty-eight subjects with light perception vision received a retinal implant. Controlled, closed-group, forced-choice letter identification, and, open-choice two-, three- and four-letter word identification tests were carried out.
    Results: The mean±SD percentage correct letter identification for 21 subjects tested were: letters L, T, E, J, F, H, I, U, 72.3±24.6% system on and 17.7±12.9% system off; letters A, Z, Q, V, N, W, O, C, D, M, 55.0±27.4% system on and 11.8%±10.7% system off, and letters K, R, G, X, B, Y, S, P, 51.7±28.9% system on and 15.3±7.4% system off. (p<0.001 for all groups). A subgroup of six subjects was able to consistently read letters of reduced size, the smallest measuring 0.9 cm (1.7°) at 30 cm, and four subjects correctly identify unrehearsed two-, three- and four-letter words. Average implant duration was 19.9 months.
    Conclusions: Multiple blind subjects fitted with the Argus II system consistently identified letters and words using the device, indicating reproducible spatial resolution. This, in combination with stable, long-term function, represents significant progress in the evolution of artificial sight.
    MeSH term(s) Adult ; Aged ; Choroideremia/physiopathology ; Choroideremia/surgery ; Electrodes, Implanted ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Prosthesis Implantation ; Reading ; Retinitis Pigmentosa/physiopathology ; Retinitis Pigmentosa/surgery ; Vision, Low/physiopathology ; Vision, Low/surgery ; Visual Acuity/physiology ; Visual Perception/physiology ; Visual Prosthesis
    Language English
    Publishing date 2013-02-20
    Publishing country England
    Document type Controlled Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 80078-8
    ISSN 1468-2079 ; 0007-1161
    ISSN (online) 1468-2079
    ISSN 0007-1161
    DOI 10.1136/bjophthalmol-2012-301525
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS: Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion.

    Rizzo, Stanislao / Barale, Pierre-Olivier / Ayello-Scheer, Sarah / Devenyi, Robert G / Delyfer, Marie-Noëlle / Korobelnik, Jean-François / Rachitskaya, Aleksandra / Yuan, Alex / Jayasundera, K Thiran / Zacks, David N / Handa, James T / Montezuma, Sandra R / Koozekanani, Dara / Stanga, Paulo E / da Cruz, Lyndon / Walter, Peter / Augustin, Albert J / Chizzolini, Marzio / Olmos de Koo, Lisa C /
    Ho, Allen C / Kirchhof, Bernd / Hahn, Paul / Vajzovic, Lejla / Iezzi, Raymond / Gaucher, David / Arevalo, J Fernando / Gregori, Ninel Z / Grisanti, Salvatore / Özmert, Emin / Yoon, Young Hee / Kokame, Gregg T / Lim, Jennifer I / Szurman, Peter / de Juan, Eugene / Rezende, Flavio A / Salzmann, Joël / Richard, Gisbert / Huang, Suber S / Merlini, Francesco / Patel, Uday / Cruz, Cynthia / Greenberg, Robert J / Justus, Sally / Cinelli, Laura / Humayun, Mark S

    Retina (Philadelphia, Pa.)

    2020  Volume 40, Issue 2, Page(s) 303–311

    Abstract: Purpose: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients.: Methods: This retrospective analysis followed the results of 274 patients ...

    Abstract Purpose: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients.
    Methods: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing.
    Results: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years.
    Conclusion: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.
    MeSH term(s) Conjunctiva/surgery ; Conjunctival Diseases/epidemiology ; Conjunctival Diseases/etiology ; Conjunctival Diseases/prevention & control ; Europe/epidemiology ; Female ; Humans ; Incidence ; Male ; Middle Aged ; Postoperative Complications/epidemiology ; Postoperative Complications/etiology ; Postoperative Complications/prevention & control ; Prosthesis Implantation/adverse effects ; Prosthesis Implantation/methods ; Retinitis Pigmentosa/surgery ; Retrospective Studies ; United States/epidemiology ; Visual Prosthesis/adverse effects
    Language English
    Publishing date 2020-01-22
    Publishing country United States
    Document type Journal Article ; Multicenter Study
    ZDB-ID 603192-4
    ISSN 1539-2864 ; 0275-004X
    ISSN (online) 1539-2864
    ISSN 0275-004X
    DOI 10.1097/IAE.0000000000002394
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  10. Article ; Online: Hypotony and the Argus II retinal prosthesis: causes, prevention and management.

    Rizzo, Stanislao / Barale, Pierre-Olivier / Ayello-Scheer, Sarah / Devenyi, Robert G / Delyfer, Marie Noelle / Korobelnik, Jean-François / Rachitskaya, Aleksandra / Yuan, Alex / Jayasundera, K Thiran / Zacks, David N / Handa, James T / Montezuma, Sandra R / Koozekanani, Dara / Stanga, Paulo / da Cruz, Lyndon / Walter, Peter / Augustin, Albert J / Olmos de Koo, Lisa C / Ho, Allen C /
    Kirchhof, Bernd / Hahn, Paul / Vajzovic, Lejla / Iezzi, Raymond / Gaucher, David / Arevalo, J Fernando / Gregori, Ninel Z / Wiedemann, Peter / Özmert, Emin / Lim, Jennifer I / Rezende, Flavio A / Huang, Suber S / Merlini, Francesco / Patel, Uday / Greenberg, Robert J / Justus, Sally / Bacherini, Daniela / Cinelli, Laura / Humayun, Mark S

    The British journal of ophthalmology

    2019  Volume 104, Issue 4, Page(s) 518–523

    MeSH term(s) Blindness/rehabilitation ; Ciliary Body/injuries ; Electrodes, Implanted ; Eye Injuries/etiology ; Humans ; Incidence ; Intraocular Pressure ; Ocular Hypotension/etiology ; Ocular Hypotension/prevention & control ; Prosthesis Implantation/adverse effects ; Retinitis Pigmentosa/therapy ; Retrospective Studies ; Sclerostomy/adverse effects ; Visual Prosthesis/adverse effects ; Wound Healing/physiology
    Language English
    Publishing date 2019-07-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 80078-8
    ISSN 1468-2079 ; 0007-1161
    ISSN (online) 1468-2079
    ISSN 0007-1161
    DOI 10.1136/bjophthalmol-2019-314135
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