First-in-human trial of a novel suprachoroidal retinal prosthesis

PLoS ONE

Volumn 9, Issue 12, 2014, Pages

  Ayton, Lauren N ^a   Blamey, Peter J ^a,b   Guymer, Robyn H ^a   Luu, Chi D ^a   Nayagam, David A X ^a,b   Sinclair, Nicholas C ^b   Shivdasani, Mohit N ^a,b   Yeoh, Jonathan ^a   McCombe, Mark F ^a   Briggs, Robert J ^a   Opie, Nicholas L ^a   Villalobos, Joel ^b   Dimitrov, Peter N ^a   Varsamidis, Mary ^a   Petoe, Matthew A ^b   McCarthy, Chris D ^c,d   Walker, Janine G ^c,d   Barnes, Nick ^c,d   Burkitt, Anthony N ^a,b   Williams, Chris E ^b   Shepherd, Robert K ^a,b   Allen, Penelope J ^a   more..

^a UNIVERSITY OF MELBOURNE   (Australia)

^b Bionics Institute   (Australia)

^c CSIRO   (Australia)

^d AUSTRALIAN NATIONAL UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORAMPHENICOL; MORPHINE; PARACETAMOL; PREDNEFRIN;

ADULT; ARTICLE; BARDET BIEDL SYNDROME; BLOOD VESSEL STAPLE; CASE REPORT; CHOROID; CLINICAL EFFECTIVENESS; CRESCENT BLADE; DEVICE SAFETY; ELECTRODE; END STAGE RETINITIS PIGMENTOSA; EYE INFLAMMATION; EYE PAIN; EYE SURGERY; FELINE MODEL; FEMALE; HEARING AID; HUMAN; LENS GLIDE; MALE; MIDDLE AGED; NYLON SUTURE; PATIENT MONITORING; PERCUTANEOUS CONNECTOR; POLYGLACTIN SUTURE; POSTOPERATIVE PERIOD; RETINA CONE; RETINA DYSTROPHY; RETINA ROD; RETINAL IMPLANT; RETINITIS PIGMENTOSA; SCLERA; SUPRACHOROIDAL RETINAL PROSTHESIS; SURGICAL EQUIPMENT; SURGICAL WIRE; TITANIUM INTERFERENCE SCREW; VISION; ADVERSE EFFECTS; CLINICAL TRIAL; DEVICES; PHASE 1 CLINICAL TRIAL; POSTOPERATIVE COMPLICATION; PROCEDURES; VISUAL PROSTHESIS;

CHOROID; FEMALE; HUMANS; MALE; MIDDLE AGED; OPHTHALMOLOGIC SURGICAL PROCEDURES; POSTOPERATIVE COMPLICATIONS; RETINITIS PIGMENTOSA; SCLERA; VISUAL PROSTHESIS;

EID: 84919476329     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0115239     Document Type: Article

References (48)

1. Chader GJ, Weiland J, Humayun MS (2009) Artificial vision: needs, functioning, and testing of a retinal electronic prosthesis. Prog Brain Res 175: 317-332.
2. Pascolini D, Mariotti SP (2012) Global estimates of visual impairment: 2010. Br J Ophthalmol 96: 614-618.
3. Zrenner E (2013) Fighting blindness with microelectronics. Sci Transl Med 5: 210ps216.
4. Shepherd RK, Shivdasani MN, Nayagam DA, Williams CE, Blamey PJ (2013) Visual prostheses for the blind. Trends Biotechnol 31: 562-571.
5. Humayun MS, Dorn JD, Ahuja AK, Caspi A, Filley E, et al. (2009) Preliminary 6 month results from the Argus II epiretinal prosthesis feasibility study. Conf Proc IEEE Eng Med Biol Soc: 4566-4568.
6. Rizzo JF, 3rd (2011) Update on retinal prosthetic research: the Boston Retinal Implant Project. J Neuroophthalmol 31: 160-168.
7. Zrenner E, Bartz-Schmidt KU, Benav H, Besch D, Bruckmann A, et al. (2011) Subretinal electronic chips allow blind patients to read letters and combine them to words. Proc Biol Sci 278: 1489-1497.
8. Stingl K, Bartz-Schmidt KU, Besch D, Braun A, Bruckmann A, et al. (2013) Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS. Proc Biol Sci 280: 20130077.
9. Stone JL, Barlow WE, Humayun MS, de Juan E Jr, Milam AH (1992) Morphometric analysis of macular photoreceptors and ganglion cells in retinas with retinitis pigmentosa. Arch Ophthalmol 110: 1634-1639.
10. Bunker CH, Berson EL, Bromley WC, Hayes RP, Roderick TH (1984) Prevalence of retinitis pigmentosa in Maine. Am J Ophthalmol 97: 357-365.
11. Santos A, Humayun MS, de Juan E Jr, Greenburg RJ, Marsh MJ, et al. (1997) Preservation of the inner retina in retinitis pigmentosa. A morphometric analysis. Arch Ophthalmol 115: 511-515.
12. Hood DC, Lin CE, Lazow MA, Locke KG, Zhang X, et al. (2009) Thickness of receptor and postreceptor retinal layers in patients with retinitis pigmentosa measured with frequency-domain optical coherence tomography. Invest Ophthalmol Vis Sci 50: 2328-2336.
13. Humayun MS, Prince M, de Juan E Jr, Barron Y, Moskowitz M, et al. (1999) Morphometric analysis of the extramacular retina from postmortem eyes with retinitis pigmentosa. Invest Ophthalmol Vis Sci 40: 143-148.
14. da Cruz L, Coley BF, Dorn J, Merlini F, Filley E, et al. (2013) The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss. Br J Ophthalmol: 632-636.
15. Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, et al. (2012) Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology 119: 779-788.
16. Fujikado T, Morimoto T, Kanda H, Kusaka S, Nakauchi K, et al. (2007) Evaluation of phosphenes elicited by extraocular stimulation in normals and by suprachoroidal-transretinal stimulation in patients with retinitis pigmentosa. Graefes Arch Clin Exp Ophthalmol 245: 1411-1419.
17. Rizzo JF, 3rd, Wyatt J, Loewenstein J, Kelly S, Shire D (2003) Methods and perceptual thresholds for short-term electrical stimulation of human retina with microelectrode arrays. Invest Ophthalmol Vis Sci 44: 5355-5361.
18. Rizzo JF, 3rd, Wyatt J, Loewenstein J, Kelly S, Shire D (2003) Perceptual efficacy of electrical stimulation of human retina with a microelectrode array during short-term surgical trials. Invest Ophthalmol Vis Sci 44: 5362-5369.
19. Fujikado T, Kamei M, Sakaguchi H, Kanda H, Morimoto T, et al. (2011) Testing of semichronically implanted retinal prosthesis by suprachoroidal-transretinal stimulation in patients with retinitis pigmentosa. Invest Ophthalmol Vis Sci 52: 4726-4733.
20. Second Sight Medical Products (2012) Sponsor Executive Summary: Prepared for the September 28, 2012 Meeting of the FDA Ophthalmic Device Advisory Panel. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM320778.pdf: Accessed 11 December 2013.
21. Stingl K, Zrenner E (2013) Electronic approaches to restitute vision in patients with neurodegenerative diseases of the retina. Ophthalmic Res 50: 215-220.
22. Ayton LN, Guymer RH, Luu CD (2013) Choroidal thickness profiles in retinitis pigmentosa. Clin Experiment Ophthalmol 41: 396-403.
23. Villalobos J, Allen PJ, McCombe MF, Ulaganathan M, Zamir E, et al. (2012) Development of a surgical approach for a wide-view suprachoroidal retinal prosthesis: evaluation of implantation trauma. Graefes Arch Clin Exp Ophthalmol 250: 399-407.
24. Villalobos J, Nayagam DA, Allen PJ, McKelvie P, Luu CD, et al. (2013) A wide-field suprachoroidal retinal prosthesis is stable and well tolerated following chronic implantation. Invest Ophthalmol Vis Sci 54: 3751-3762.
25. Cicione R, Shivdasani MN, Fallon JB, Luu CD, Allen PJ, et al. (2012) Visual cortex responses to suprachoroidal electrical stimulation of the retina: effects of electrode return configuration. J Neural Eng 9: 036009.
26. Shivdasani MN, Fallon JB, Luu CD, Cicione R, Allen PJ, et al. (2012) Visual cortex responses to single- and simultaneous multiple-electrode stimulation of the retina: implications for retinal prostheses. Invest Ophthalmol Vis Sci 53: 6291-6300.
27. van den Honert C, Kelsall DC (2007) Focused intracochlear electric stimulation with phased array channels. J Acoust Soc Am 121: 3703-3716.
28. Ayton LN, Apollo NV, Varsamidis M, Dimitrov PN, Guymer RH, et al. (2014) Assessing residual visual function in severe vision loss. Invest Ophthalmol Vis Sci 55: 1332-1338.
29. Finger RP, Tellis B, Crewe J, Keeffe JE, Ayton LN, et al. (2014) Developing the Impact of Vision Impairment-Very Low Vision (IVI-VLV) Questionnaire as Part of the LoVADA Protocol. Invest Ophthalmol Vis Sci 55: 6150-6158.
30. Bittner AK, Haythornthwaite JA, Diener-West M, Dagnelie G (2013) Worse-than-usual visual fields measured in retinitis pigmentosa related to episodically decreased general health. Br J Ophthalmol 97: 145-148.
31. Bittner AK, Ibrahim MA, Haythornthwaite JA, Diener-West M, Dagnelie G (2011) Vision test variability in retinitis pigmentosa and psychosocial factors. Optom Vis Sci 88: 1496-1506.
32. Abramian M, Lovell NH, Morley JW, Suaning GJ, Dokos S (2011) Activation of retinal ganglion cells following epiretinal electrical stimulation with hexagonally arranged bipolar electrodes. J Neural Eng 8: 035004.
33. Saunders AL, Williams CE, Heriot W, Briggs R, Yeoh J, et al. (2014) Development of a surgical procedure for implantation of a prototype suprachoroidal retinal prosthesis. Clin Experiment Ophthalmol 42: 665-674.
34. John SE, Shivdasani MN, Leuenberger J, Fallon JB, Shepherd RK, et al. (2011) An automated system for rapid evaluation of high-density electrode arrays in neural prostheses. J Neural Eng 8: 036011.
35. Bach M, Wilke M, Wilhelm B, Zrenner E, Wilke R (2010) Basic quantitative assessment of visual performance in patients with very low vision. Invest Ophthalmol Vis Sci 51: 1255-1260.
36. Bach M (1996) The Freiburg Visual Acuity test-automatic measurement of visual acuity. Optom Vis Sci 73: 49-53.
37. Dacey DM, Petersen MR (1992) Dendritic field size and morphology of midget and parasol ganglion cells of the human retina. Proc Natl Acad Sci U S A 89: 9666-9670.
38. Lieby P, Barnes N, Walker JG, Scott AF, Barnes N, et al. (2013) Evaluating Lanczos2 image filtering for visual acuity in simluated prosthetic vision. Association for Research in Vision and Ophthalmology (ARVO) annual meeting. Seattle, USA.
39. Barnes N, Scott AF, Stacey A, Lieby P, McCarthy C, et al. (2014) Vision Processing with Lanczos2 Improves Low Vision Test Results in Implanted Visual Prosthetics. Association for Research in Vision and Ophthalmology annual meeting. Orlando, FL.
40. Nayagam DA, Williams RA, Allen PJ, Shivdasani MN, Luu CD, et al. (2014) Chronic electrical stimulation with a suprachoroidal retinal prosthesis: a preclinical safety and efficacy study. PLOS One 9: e97182.
41. Allen PJ, Yeoh J, McCombe MF, Heriot WJ, Luu CD, et al. (2013) Implantation of a suprachoroidal retinal prosthesis results in number and letter recognition; Seattle, USA.
42. Huang CQ, Shepherd RK, Carter PM, Seligman PM, Tabor B (1999) Electrical stimulation of the auditory nerve: Direct current measurement in vivo. IEEE Trans Biomed Eng 46: 461-470.
43. Merrill DR, Bikson M, Jefferys JG (2005) Electrical stimulation of excitable tissue: design of efficacious and safe protocols. J Neurosci Methods 141: 171-198.
44. Blamey PJ, Sinclair NC, Slater K, McDermott HJ, Perera T, et al. Psychophysics of a suprachoroidal retinal prosthesis; 2013; Seattle, USA.
45. Leung RT, Nayagam DA, Williams RA, Allen PJ, Salinas-La Rosa CM, et al. (2014) Safety and efficacy of explanting or replacing suprachoroidal electrode arrays in a feline model. Clin Experiment Ophthalmol In press.
46. Bron A, Tripathi R, Tripathi B (1998) Wolff's Anatomy of the Eye and Orbit. London: Chapman & Hall.
47. Shivdasani MN, Sinclair NC, Dimitrov PN, Varsamidis M, Ayton LN, et al. (2014) Factors affecting perceptual thresholds in a suprachoroidal retinal prosthesis. Invest Ophthal Vis Sci 55: 6467-6481.
48. Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, et al. (2013) Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci 54: 7658-7665.