Subretinal Visual Implant Alpha IMS - Clinical trial interim report

Vision Research

Volumn 111, Issue , 2015, Pages 149-160

  Stingl, Katarina ^a   Bartz Schmidt, Karl Ulrich ^a   Besch, Dorothea ^a   Chee, Caroline K ^b   Cottriall, Charles L ^c   Gekeler, Florian ^a,d   Groppe, Markus ^c   Jackson, Timothy L ^e   MacLaren, Robert E ^c   Koitschev, Assen ^f   Kusnyerik, Akos ^g   Neffendorf, James ^e   Nemeth, Janos ^g   Naeem, Mohamed Adheem Naser ^b   Peters, Tobias ^h   Ramsden, James D ^k   Sachs, Helmut ⁱ   Simpson, Andrew ^e   Singh, Mandeep S ^b   Wilhelm, Barbara ^h   Wong, David ^j   Zrenner, Eberhart ^a,h   more..

^a UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^b NATIONAL UNIVERSITY HEALTH SYSTEM   (Singapore)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d KATHARINENHOSPITAL   (Germany)

^e KING S COLLEGE HOSPITAL   (United Kingdom)

^f OLGAHOSPITAL   (Germany)

^g SEMMELWEIS UNIVERSITY   (Hungary)

^h UNIVERSITY OF TÜBINGEN   (Germany)

ⁱ ACADEMIC TEACHING HOSPITAL DRESDEN FRIEDRICHSTADT   (Germany)

^j UNIVERSITY OF HONG KONG   (Hong Kong)

^k OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

more..

Author keywords

Artificial vision; Hereditary retinal diseases; Neuroprosthetics; Photoreceptor degeneration; Retinitis pigmentosa; Subretinal Implant Alpha IMS

Indexed keywords

ADULT; AGED; ARTICLE; BLINDNESS; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DEVICE SAFETY; FEMALE; GENETIC DISORDER; HUMAN; INTRAOCULAR PRESSURE ABNORMALITY; MALE; MULTICENTER STUDY; OPHTHALMOLOGICAL IMPLANT; PRIORITY JOURNAL; RETINA DEGENERATION; RETINA DETACHMENT; SUBRETINAL VISUAL IMPLANT; TREATMENT OUTCOME; VISUAL ACUITY; VISUAL MEMORY; CLINICAL TRIAL; COMPLICATION; ELECTRODE IMPLANT; MIDDLE AGED; MOVEMENT PERCEPTION; PATHOPHYSIOLOGY; PATTERN RECOGNITION; PHYSIOLOGY; RETINITIS PIGMENTOSA; VISION;

ACTIVITIES OF DAILY LIVING; ADULT; AGED; BLINDNESS; ELECTRODES, IMPLANTED; FEMALE; FORM PERCEPTION; HUMANS; MALE; MIDDLE AGED; MOTION PERCEPTION; RETINAL DEGENERATION; RETINITIS PIGMENTOSA; VISUAL ACUITY; VISUAL PERCEPTION;

EID: 84941315108     PISSN: 00426989     EISSN: 18785646     Source Type: Journal    
DOI: 10.1016/j.visres.2015.03.001     Document Type: Article

References (48)

1. Ayton L.N., et al. First-in-human trial of a novel suprachoroidal retinal prosthesis. PLoS One 2014, 9(12):e115239. 10.1371/journal.pone.0115239.
2. Bach M., et al. Basic quantitative assessment of visual performance in patients with very low vision. Investigative Ophthalmology & Visual Science 2010, 51(2):1255-1260. 10.1167/iovs.09-3512.
3. Bainbridge J.W.B., et al. Effect of gene therapy on visual function in Leber's congenital amaurosis. The New England Journal of Medicine 2008, 358(21):2231-2239. 10.1056/NEJMoa0802268.
4. Besch D., et al. Extraocular surgery for implantation of an active subretinal visual prosthesis with external connections: Feasibility and outcome in seven patients. British Journal of Ophthalmology 2008, 92(10):1361-1368. 10.1136/bjo.2007.131961.
5. Brelén M.E., et al. Measurement of evoked potentials after electrical stimulation of the human optic nerve. Investigative Ophthalmology & Visual Science 2010, 51(10):5351-5355. 10.1167/iovs.09-4346.
6. Busskamp V., et al. Optogenetic therapy for retinitis pigmentosa. Gene Therapy 2012, 19(2):169-175. 10.1038/gt.2011.155.
7. Chow A.Y., et al. The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa. Archives of Ophthalmology 2004, 122(4):460-469. 10.1001/archopht.122.4.460.
8. Chow A.Y., et al. The artificial silicon retina in retinitis pigmentosa patients (an American Ophthalmological Association thesis). Transactions of the American Ophthalmological Society 2010, 108:120-154.
9. Eickenscheidt M., et al. Electrical stimulation of retinal neurons in epiretinal and subretinal configuration using a multicapacitor array. Journal of Neurophysiology 2012, 107(10):2742-2755. 10.1152/jn.00909.2011.
10. Food and Drug Administration. Investigational Device Exemption Guidance for Retinal Prostheses (2013). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm341954.htm.
11. Gekeler F., et al. Compound subretinal prostheses with extra-ocular parts designed for human trials: Successful long-term implantation in pigs. Graefe's Archive for Clinical and Experimental Ophthalmology 2007, 245(2):230-241. 10.1007/s00417-006-0339-x.
12. Guenther E., et al. Long-term survival of retinal cell cultures on retinal implant materials. Vision Research 1999, 39(24):3988-3994.
13. Guenther T., Lovell N.H., Suaning G.J. Bionic vision: System architectures: A review. Expert Review of Medical Devices 2012, 9(1):33-48. 10.1586/erd.11.58.
14. Humayun M.S., et al. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology 2012, 119(4):779-788. 10.1016/j.ophtha.2011.09.028.
15. Katz B., Sireteanu R. The Teller Acuity Card Test: Possibilities and limits of clinical use. Klinische Monatsblätter für Augenheilkunde 1989, 195(1):17-22. 10.1055/s-2008-1046406.
16. Kernstock C.J., et al. 3D-visualisation of power supply cable of subretinal electronic implants during eye movement. ARVO Meeting Abstracts 2011, 52(6):1341.
17. Kitiratschky V.B.D., et al. Safety evaluation of 'retina implant alpha IMS' - A prospective clinical trial. Graefe's Archive for Clinical and Experimental Ophthalmology 2014, 10.1007/s00417-014-2797-x.
18. Kohler K., et al. Histological studies of retinal degeneration and biocompatibility of subretinal implants. Der Ophthalmologe 2001, 98(4):364-368. 10.1007/s003470170142.
19. Kusnyerik A., et al. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Investigative Ophthalmology & Visual Science 2012, 53(7):3748-3755. 10.1167/iovs.11-9409.
20. Luo Y.H.-L., da Cruz L. A review and update on the current status of retinal prostheses (bionic eye). British Medical Bulletin 2014, 109:31-44. 10.1093/bmb/ldu002.
21. Maguire A.M., et al. Age-dependent effects of RPE65 gene therapy for Leber's congenital amaurosis: A phase 1 dose-escalation trial. Lancet 2009, 374(9701):1597-1605. 10.1016/S0140-6736(09)61836-5.
22. Menzel-Severing J., et al. Implantation and explantation of an active epiretinal visual prosthesis: 2-year follow-up data from the EPIRET3 prospective clinical trial. Eye (London, England) 2012, 26(4):501-509. 10.1038/eye.2012.35.
23. Morimoto T., et al. Transcorneal electrical stimulation promotes survival of photoreceptors and improves retinal function in rhodopsin P347L transgenic rabbits. Investigative Ophthalmology & Visual Science 2012, 53(7):4254-4261. 10.1167/iovs.11-9067.
24. Nau A., Bach M., Fisher C. Clinical tests of ultra-low vision used to evaluate rudimentary visual perceptions enabled by the brainport vision device. Translational Vision Science & Technology 2015, 2(3):1.
25. Pardue M.T., et al. Neuroprotective effect of subretinal implants in the RCS rat. Investigative Ophthalmology & Visual Science 2005, 46(2):674-682. 10.1167/iovs.04-0515.
26. Sachs H., et al. Subretinal implant: The intraocular implantation technique. Nova Acta Leopoldina NF III 2010, 379:217-223.
27. Santos A., et al. Preservation of the inner retina in retinitis pigmentosa. A morphometric analysis. Archives of Ophthalmology 1997, 115(4):511-515.
28. Schatz A., et al. Transcorneal electrical stimulation for patients with retinitis pigmentosa: A prospective, randomized, sham-controlled exploratory study. Investigative Ophthalmology & Visual Science 2011, 52(7):4485-4496. 10.1167/iovs.10-6932.
29. Schmid H., et al. Neuroprotective effect of transretinal electrical stimulation on neurons in the inner nuclear layer of the degenerated retina. Brain Research Bulletin 2009, 79(1):15-25. 10.1016/j.brainresbull.2008.12.013.
30. Schmidt E.M., et al. Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. Brain: A Journal of Neurology 1996, 119(Pt. 2):507-522.
31. Schwahn H., et al. Studies on the feasibility of a subretinal visual prosthesis: Data from Yucatan micropig and rabbit. Graefe's Archive for Clinical and Experimental Ophthalmology 2001, 239(12):961-967. 10.1007/s004170100368.
32. Sieving P.A., et al. Ciliary neurotrophic factor (CNTF) for human retinal degeneration: Phase I trial of CNTF delivered by encapsulated cell intraocular implants. Proceedings of the National Academy of Sciences of the United States of America 2006, 103(10):3896-3901. 10.1073/pnas.0600236103.
33. Stett A., et al. Electrical multisite stimulation of the isolated chicken retina. Vision Research 2000, 40(13):1785-1795. 10.1016/S0042-6989(00)00005-5.
34. Stingl K., et al. What can blind patients see in daily life with the subretinal Alpha IMS implant? Current overview from the clinical trial in Tübingen. Der Ophthalmologe 2012, 109(2):136-141. 10.1007/s00347-011-2479-6.
35. Stingl K., et al. Safety and efficacy of subretinal visual implants in humans: Methodological aspects. Clinical & Experimental Optometry 2013, 96(1):4-13. 10.1111/j.1444-0938.2012.00816.x.
36. Stingl K., et al. Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS. Proceedings of the Royal Society B: Biological Sciences 2013, 280(1757). 10.1098/rspb.2013.0077.
37. Stingl K., et al. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Investigative Ophthalmology & Visual Science 2013, 54(12):7658-7665. 10.1167/iovs.13-12835.
38. Stingl K., Zrenner E. Electronic approaches to restitute vision in patients with neurodegenerative diseases of the retina. Ophthalmic Research 2013, 50(4):215-220. 10.1159/000354424.
39. Striem-Amit E., et al. Visual' acuity of the congenitally blind using visual-to-auditory sensory substitution. PLoS ONE 2012, 7(3):e33136. 10.1371/journal.pone.0033136 '.
40. Testa F., et al. Three-year follow-up after unilateral subretinal delivery of adeno-associated virus in patients with Leber congenital Amaurosis type 2. Ophthalmology 2013, 120(6):1283-1291. 10.1016/j.ophtha.2012.11.048.
41. The Lasker/IRRF Initiative for Innovation in Vision Science Restoring vision to the blind: The new age of implanted visual prostheses. Translational Vision Science & Technology 2014, 3(7). 10.1167/tvst.3.7.3.
42. The Lasker/IRRF Initiative for Innovation in Vision Science Restoring vision to the blind: Advancements in vision aids for the visually impaired. Translational Vision Science & Technology 2014, 3(7). 10.1167/tvst.3.7.9.
43. Weiland J.D., Cho A.K., Humayun M.S. Retinal prostheses: Current clinical results and future needs. Ophthalmology 2011, 118(11):2227-2237. 10.1016/j.ophtha.2011.08.042.
44. Zrenner E., et al. Can subretinal microphotodiodes successfully replace degenerated photoreceptors?. Vision Research 1999, 39(15):2555-2567. 10.1016/s0042-6989(98)00312-5.
45. Zrenner E. Will retinal implants restore vision?. Science (New York, N.Y.) 2002, 295(5557):1022-1025. 10.1126/science.1067996.
46. Zrenner E., et al. Subretinal electronic chips allow blind patients to read letters and combine them to words. Proceedings of the Royal Society B: Biological Sciences 2011, 278(1711):1489-1497. 10.1098/rspb.2010.1747.
47. Zrenner E. Artificial vision: Solar cells for the blind. Nature Photonics 2012, 6(6):344-345. 10.1038/nphoton.2012.114.
48. Zrenner E. Fighting blindness with microelectronics. Science Translational Medicine 2013, 5(210):210ps16. 10.1126/scitranslmed.3007399.