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Fontanarosa J, Treadwell JR, Samson DJ, et al. Retinal Prostheses in the Medicare Population [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Sep 30. (Technology Assessments, No. 103.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

References

1.
Heckenlively JR. Retinitis pigmentosa. Philadelphia (PA): Lippincott; 1988. 269 p.
2.
Bunker CH, Berson EL, Bromley WC, et al. Prevalence of retinitis pigmentosa in Maine. Am J Ophthalmol. 1984 Mar;97(3):357–65. [PubMed: 6702974]
3.
Grondahl J. Estimation of prognosis and prevalence of retinitis pigmentosa and Usher syndrome in Norway. Clin Genet. 1987 Apr;31(4):255–64. [PubMed: 3594933]
4.
Hartong DT, Berson EL, Dryja TP. Retinitis pigmentosa. Lancet. 2006 Nov 18;368(9549):1795–809. Also available: http://dx​.doi.org/10​.1016/S0140-6736(06)69740-7. [PubMed: 17113430]
5.
Haim M. Epidemiology of retinitis pigmentosa in Denmark. Acta Ophthalmol Scand Suppl. 2002;(233):1–34. [PubMed: 11921605]
6.
Guadagni V, Novelli E, Piano I, Gargini C, Strettoi E. Pharmacological approaches to retinitis pigmentosa: A laboratory perspective. Prog Retin Eye Res. 2015 Sep;48:62–81. Also available: http://dx​.doi.org/10​.1016/j.preteyeres.2015.06.005. [PubMed: 26113212]
7.
Tanino T, Ohba N. Studies on pigmentary retinal dystrophy. II. Recordability of electroretinogram and the mode of inheritance. Jpn J Ophthalmol. 1976;20:482–6.
8.
Taylor HR. LXIII Edward Jackson Memorial Lecture: Eye care: dollars and sense. Am J Ophthalmol. 2007 Jan;143(1):1–8. Also available: http://dx​.doi.org/10​.1016/j.ajo.2006.10.003. [PubMed: 17188039]
9.
Hahm BJ, Shin YW, Shim EJ, et al. Depression and the vision-related quality of life in patients with retinitis pigmentosa. Br J Ophthalmol. 2008 May;92(5):650–4. Also available: http://dx​.doi.org/10​.1136/bjo.2007.127092. [PubMed: 18356260]
10.
Second Sight Medical Products. ClinicalTrials​.gov. Bethesda (MD): National Library of Medicine (U.S.); 2000. [2015 Jul 02]. Argus II retinal prosthesis system dry AMD feasibility study protocol. [database online] [4 p] Available: https:​//clinicaltrials​.gov/ct2/show/NCT022274. NLM Identifier: NCT02227498.
11.
Bowling B. Kanski's Clinical Ophthalmology: A Systematic Approach. 8th ed. Philadelphia (PA): Elsevier; Acquired macular disorders; pp. 2016pp. 579–639.
12.
American Academy of Ophthalmology Retina/Vitreous Panel. Preferred practice pattern guidelines. Age-related macular degeneration. San Francisco (CA): American Academy of Ophthalmology (AAO); Jan, 2015. 52 p. Also available: http://www​.aao.org/ppp.
13.
Ferris FL, Wilkinson CP, Bird A, et al. Clinical classification of age-related macular degeneration. Ophthalmology. 2013 Apr;120(4):844–51. Also available: http://dx​.doi.org/10​.1016/j.ophtha.2012.10.036. [PubMed: 23332590]
14.
Zrenner E, Bartz-Schmidt KU, Benav H, et al. Subretinal electronic chips allow blind patients to read letters and combine them to words. Proc Biol Sci. 2011 May 22;278(1711):1489–97. Epub 2010 Nov 3. [PMC free article: PMC3081743] [PubMed: 21047851]
15.
Humayun MS, Dorn JD, da Cruz L, et al. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779–88. [PMC free article: PMC3319859] [PubMed: 22244176]
16.
Dobelle WH, Quest DO, Antunes JL, et al. Artificial vision for the blind by electrical stimulation of the visual cortex. Neurosurgery. 1979 Oct;5(4):521–7. [PubMed: 534058]
17.
Veraart C, Raftopoulos C, Mortimer JT, et al. Visual sensations produced by optic nerve stimulation using an implanted self-sizing spiral cuff electrode. Brain Res. 1998 Nov 30;813(1):181–6. [PubMed: 9824694]
18.
Ayton LN, Blamey PJ, Guymer RH, et al. First-in-human trial of a novel suprachoroidal retinal prosthesis. PLoS ONE. 2014 Dec 18;9(12):e115239. Also available: http://dx​.doi.org/10​.1371/journal.pone.0115239. [PMC free article: PMC4270734] [PubMed: 25521292]
19.
U.S. Food and Drug Administration (FDA); Center for Devices and Radiological Health (CDRH). Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) Investigational Device Exemption (IDE) guidance for retinal prostheses. Silver Spring (MD): U.S Food and Drug Administration (FDA); Mar 6, 2013. 25 p. Also available: http://www​.fda.gov/RegulatoryInformation​/Guidances/ucm341954.htm.
20.
Keseru M, Feucht M, Bornfeld N, et al. Acute electrical stimulation of the human retina with an epiretinal electrode array. Acta Ophthalmol. 2012 Feb;90(1):e1–8. Also available: http://dx​.doi.org/10​.1111/j.1755-3768.2011.02288.x. [PubMed: 22067614]
21.
Stingl K, Bartz-Schmidt KU, Gekeler F, et al. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov;54(12):7658–65. Also available: http://dx​.doi.org/10.1167/iovs.13-12835. [PubMed: 24150759]
22.
Chow AY, Chow VY, Packo KH, et al. The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa. Arch Ophthalmol. 2004;122(4):460–9. [PubMed: 15078662]
23.
Fujikado T, Kamei M, Sakaguchi H, et al. Testing of semichronically implanted retinal prosthesis by suprachoroidal-transretinal stimulation in patients with retinitis pigmentosa. Invest Ophthalmol Vis Sci. 2011 Jun;52(7):4726–33. Also available: http://dx​.doi.org/10.1167/iovs.10-6836. [PubMed: 21436271]
24.
Rizzo JF, Shire DB, Kelly SK, et al. Overview of the Boston retinal prosthesis: challenges and opportunities to restore useful vision to the blind. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:7492–5. Also available: http://dx​.doi.org/10​.1109/IEMBS.2011.6093610. [PMC free article: PMC7448726] [PubMed: 22256071]
25.
Mandel Y, Goetz G, Lavinsky D, et al. Cortical responses elicited by photovoltaic subretinal prostheses exhibit similarities to visually evoked potentials. Nat Commun. 2013;4:1980. Also available: http://dx​.doi.org/10.1038/ncomms2980. [PMC free article: PMC4249937] [PubMed: 23778557]
26.
Alamusi, Matsuo T, Hosoya O, et al. Vision maintenance and retinal apoptosis reduction in RCS rats with Okayama University-type retinal prosthesis (OURePTM) implantation. J Artif Organs. 2015 Sep;18(3):264–71. Also available: http://dx​.doi.org/10​.1007/s10047-015-0825-1. [PubMed: 25732059]
27.
Dodson B. Bio-Retina to enter clinical trials in 2013. Gizmag. Jul 20, 2012. [2016 Jul 25]. [internet] [7 p] Available: http://www​.gizmag.com​/bio-retina-restore-vision-blind/23387/
28.
Fan LS, inventor; Iridium Medical Technology Co., Ltd. , assignee. Flexible artificial retina devices. United States patent US 9114004. 2015 Aug 25;
29.
Yue L, Falabella P, Christopher P, et al. Ten-year follow-up of a blind patient chronically implanted with epiretinal prosthesis Argus I. Ophthalmology. 2015 Dec;122(12):2545–52.e1. Epub 2015 Sep 18. Also available: http://dx​.doi.org/10​.1016/j.ophtha.2015.08.008. [PubMed: 26386850]
30.
Ho AC, Humayun MS, Dorn JD, et al. Long-term results from an epiretinal prosthesis to restore sight to the blind. Ophthalmology. 2015 Aug;122(8):1547–54. Also available: http://dx​.doi.org/10​.1016/j.ophtha.2015.04.032. [PMC free article: PMC4516690] [PubMed: 26162233]
31.
Geruschat DR, Flax M, Tanna N, et al. FLORA: Phase I development of a functional vision assessment for prosthetic vision users. Clin Exp Optom. 2015 Jul;98(4):342–7. Also available: http://dx​.doi.org/10.1111/cxo.12242. [PMC free article: PMC4481161] [PubMed: 25675964]
32.
Personal communication. 2016. KI Reviewer. 1 p.
33.
Hoffman DR, Locke KG, Wheaton DH, et al. A randomized, placebo-controlled clinical trial of docosahexaenoic acid supplementation for X-linked retinitis pigmentosa. Am J Ophthalmol. 2004 Apr;137(4):704–18. Also available: http://dx​.doi.org/10​.1016/j.ajo.2003.10.045. [PubMed: 15059710]
34.
Wheaton DH, Hoffman DR, Locke KG, et al. Biological safety assessment of docosahexaenoic acid supplementation in a randomized clinical trial for X-linked retinitis pigmentosa. Arch Ophthalmol. 2003 Sep;121(9):1269–78. Also available: http://dx​.doi.org/10​.1001/archopht.121.9.1269. [PubMed: 12963609]
35.
Aleman TS, Duncan JL, Bieber ML, et al. Macular pigment and lutein supplementation in retinitis pigmentosa and Usher syndrome. Invest Ophthalmol Vis Sci. 2001 Jul;42(8):1873–81. [PubMed: 11431456]
36.
Berson EL, Rosner B, Sandberg MA, et al. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761–72. [PubMed: 8512476]
37.
Berson EL, Rosner B, Sandberg MA, et al. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306–14. Also available: http://dx​.doi.org/10​.1001/archopht.122.9.1306. [PubMed: 15364709]
38.
Berson EL, Rosner B, Sandberg MA, et al. Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A. Arch Ophthalmol. 2010 Apr;128(4):403–11. Also available: http://dx​.doi.org/10​.1001/archophthalmol.2010.32. [PMC free article: PMC2987594] [PubMed: 20385935]
39.
Bendich A, Langseth L. Safety of vitamin A. Am J Clin Nutr. 1989 Feb;49(2):358–71. [PubMed: 2492745]
40.
Evans K, HickeyDwyer MU. Cleft anterior segment with maternal hypervitaminosis A. Br J Ophthalmol. 1991 Nov;75(11):691–2. [PMC free article: PMC1042532] [PubMed: 1751468]
41.
Rothman KJ, Moore LL, Singer MR, et al. Teratogenicity of high vitamin A intake. New Eng J Med. 1995 Nov 23;333(21):1369–73. Also available: http://dx​.doi.org/10​.1056/NEJM199511233332101. [PubMed: 7477116]
42.
Melhus H, Michaelsson K, Kindmark A, et al. Excessive dietary intake of vitamin A is associated with reduced bone mineral density and increased risk for hip fracture. Ann Intern Med. 1998 Nov 15;129(10):770–8. [PubMed: 9841582]
43.
Feskanich D, Singh V, Willett WC, et al. Vitamin A intake and hip fractures among postmenopausal women. JAMA. 2002 Jan 2;287(1):47–54. [PubMed: 11754708]
44.
Schatz A, Rock T, Naycheva L, et al. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun;52(7):4485–96. Also available: http://dx​.doi.org/10.1167/iovs.10-6932. [PubMed: 21467183]
45.
Birch DG, Weleber RG, Duncan JL, et al. Randomized trial of ciliary neurotrophic factor delivered by encapsulated cell intraocular implants for retinitis pigmentosa. Am J Ophthalmol. 2013 Aug;156(2):283–292.e1. Epub 2013 May 10. Also available: http://dx​.doi.org/10​.1016/j.ajo.2013.03.021. [PMC free article: PMC4111936] [PubMed: 23668681]
46.
Ferrari MP, Mantelli F, Sacchetti M, et al. Safety and pharmacokinetics of escalating doses of human recombinant nerve growth factor eye drops in a double-masked, randomized clinical trial. Biodrugs. 2014 Jun;28(3):275–83. Also available: http://dx​.doi.org/10​.1007/s40259-013-0079-5. [PMC free article: PMC4030100] [PubMed: 24327173]
47.
Maguire AM, High KA, Auricchio A, et al. Age-dependent effects of RPE65 gene therapy for Leber's congenital amaurosis: a phase 1 dose-escalation trial. Lancet. 2009 Nov 7;374(9701):1597–605. Also available: http://dx​.doi.org/10​.1016/S0140-6736(09)61836-5. [PMC free article: PMC4492302] [PubMed: 19854499]
48.
Maguire AM, Simonelli F, Pierce EA, et al. Safety and efficacy of gene transfer for Leber's congenital amaurosis. N Engl J Med. 2008 May 22;358(21):2240–8. Also available: http://dx​.doi.org/10.1056/NEJMoa0802315. [PMC free article: PMC2829748] [PubMed: 18441370]
49.
Hauswirth WW, Aleman TS, Kaushal S, et al. Treatment of leber congenital amaurosis due to RPE65 mutations by ocular subretinal injection of adeno-associated virus gene vector: short-term results of a phase I trial. Hum Gene Ther. 2008 Oct;19(10):979–90. Also available: http://dx​.doi.org/10.1089/hum.2008.107. [PMC free article: PMC2940541] [PubMed: 18774912]
50.
Bainbridge JW, Smith AJ, Barker SS, et al. Effect of gene therapy on visual function in Leber's congenital amaurosis. N Engl J Med. 2008 May 22;358(21):2231–9. Also available: http://dx​.doi.org/10.1056/NEJMoa0802268. [PubMed: 18441371]
51.
MacLaren RE, Groppe M, Barnard AR, et al. Retinal gene therapy in patients with choroideremia: initial findings from a phase 1/2 clinical trial. Lancet. 2014 Mar 29;383(9923):1129–37. Also available: http://dx​.doi.org/10​.1016/S0140-6736(13)62117-0. [PMC free article: PMC4171740] [PubMed: 24439297]
52.
Russell SR, Bennett J, High KA, et al. Phase 3 trial of AAV2- hRPE65v2 (SPK-RPE65) to treat RPE65-mediated inherited retinal dystrophies (IRDs): top-line safety and efficacy results. The Retina Society Annual Meeting; 2015 Oct 7-11; Paris (France). Oct 10, 2015.
53.
Maguire AM, Russell SR, Bennett J, et al. Phase 3 trial of AAV2-hRPE65v2 (SPK-RPE65) to treat RPE65-mediated inherited retinal degenerations. American Academy of Ophthalmology Annual Meeting; 2015 Nov 14-17; Las Vegas (NV). Nov 15, 2015.
54.
Cideciyan AV, Jacobson SG, Beltran WA, et al. Human retinal gene therapy for Leber congenital amaurosis shows advancing retinal degeneration despite enduring visual improvement. Proc Natl Acad Sci U S A. 2013 Feb 5;110(6):E517–25. Also available: http://dx​.doi.org/10​.1073/pnas.1218933110. [PMC free article: PMC3568385] [PubMed: 23341635]
55.
Koenekoop RK, Sui R, Sallum J, et al. Oral 9-cis retinoid for childhood blindness due to Leber congenital amaurosis caused by RPE65 or LRAT mutations: an open-label phase 1b trial. Lancet. 2014 Oct 25;384(9953):1513–20. Also available: http://dx​.doi.org/10​.1016/S0140-6736(14)60153-7. [PubMed: 25030840]
56.
Zheng A, Li Y, Tsang SH. Personalized therapeutic strategies for patients with retinitis pigmentosa. Expert Opin Biol Ther. 2015 Mar;15(3):391–402. Also available: http://dx​.doi.org/10​.1517/14712598.2015.1006192. [PMC free article: PMC4377130] [PubMed: 25613576]
57.
Blenkinsop TA, Corneo B, Temple S, et al. Ophthalmologic stem cell transplantation therapies. Regen Med. 2012 Nov;7(6 Suppl):32–9. Also available: http://dx​.doi.org/10.2217/rme.12.77. [PMC free article: PMC3582380] [PubMed: 23210809]
58.
Siqueira RC, Messias A, Messias K, et al. Quality of life in patients with retinitis pigmentosa submitted to intravitreal use of bone marrow-derived stem cells (Reticell -clinical trial). Stem Cell Res Ther. 2015 Mar 14;6:29. Also available: http://dx​.doi.org/10​.1186/s13287-015-0020-6. [PMC free article: PMC4393588] [PubMed: 25890251]
59.
Markowitz SN. Current options in low vision rehabilitation. Geriatr Aging. 2009;12(4):208–11. Also available: http://www​.medscape.com​/viewarticle/705285_print.
60.
Geruschat Duane R, Dagnelie Gislin. Restoration of vision following long-term blindness: considerations for providing rehabilitation. J Vis Impair Blind. 110(1):5–14.
61.
Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation. 2010 May;19(4):539–49. Also available: http://dx​.doi.org/10​.1007/s11136-010-9606-8. [PMC free article: PMC2852520] [PubMed: 20169472]
62.
Methods guide for effectiveness and comparative effectiveness reviews. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); Jan, 2014. AHRQ Publication No. 10(14)-EHC063-EF. 384 p. Also available: http://www​.effectivehealthcare.ahrq.gov.
63.
Stingl K, BartzSchmidt KU, Besch D, et al. Subretinal visual implant alpha IMS - clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149–60. Also available: http://dx​.doi.org/10​.1016/j.visres.2015.03.001. [PubMed: 25812924]
64.
Stingl K, Bach M, Bartz-Schmidt KU, et al. Safety and efficacy of subretinal visual implants in humans: methodological aspects. Clin Exp Optom. 2013 Jan;96(1):4–13. Also available: http://dx​.doi.org/10​.1111/j.1444-0938.2012.00816.x. [PubMed: 23173814]
65.
Arevalo JF, Al Rashaed S, Kahtani ES, et al. The Argus II retinal prosthesis in RP patients: surgical and functional outcomes from the KKESH Collaborative Retina Study Group [slide presentation]. Baltimore (MD): Johns Hopkins Medicine, Wilmer Eye Institute; Nov 15, 2015. [internet] 27 slides.
66.
Arevalo JF, Mura M, Al Rashaed S. The Argus II retinal prosthesis: surgical and functional outcomes in younger retinitis pigmentosa (RP) patients [poster PO267; slide set]. American Academy of Ophthalmology 2015 annual meeting; 2015 Nov 14-17; Las Vegas (NV). American Academy of Ophthalmology (AAO); 2015. Also available: http://aao​.scientificposters.com.
67.
Luo YH, Zhong JJ, da Cruz L. The use of Argus® II retinal prosthesis by blind subjects to achieve localisation and prehension of objects in 3-dimensional space. Graefes Arch Clin Exp Ophthalmol. 2015 Nov;253(11):1907–14. Epub 2014 Dec 31. Also available: http://dx​.doi.org/10​.1007/s00417-014-2912-z. [PubMed: 25547618]
68.
De Juan E Jr, Spencer R, Barale PO, et al. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471–6. Also available: http://dx​.doi.org/10​.1007/s00417-013-2452-y. [PMC free article: PMC3893278] [PubMed: 24013578]
69.
Greenberg RJ, Humayun MS, da Cruz L, et al. Five-year data from the Argus II retinal prosthesis system clinical trial. Invest Ophthalmol Vis Sci. 2015 Jun;56(7):754. Also available: http://iovs​.arvojournals​.org/article.aspx?articleid​=2336475&resultClick​=1.
70.
Luo YH, Davagnanam I, Dacruz L. MRI brain scans in two patients with the Argus II retinal prosthesis. Ophthalmology. 2013 Aug;120(8):1711–1711.e8. Also available: http://dx​.doi.org/10​.1016/j.ophtha.2013.04.021. [PubMed: 23916083]
71.
Lauritzen TZ, Harris J, Mohand-Said S, et al. Reading visual braille with a retinal prosthesis. Front Neurosci. 2012;6:168. [PMC free article: PMC3504310] [PubMed: 23189036]
72.
Da Cruz L, Coley BF, Dorn J, et al. The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss. Br J Ophthalmol. 2013 May;97(5):632–6. Also available: http://dx​.doi.org/10​.1136/bjophthalmol-2012-301525. [PMC free article: PMC3632967] [PubMed: 23426738]
73.
Barry MP, Dagnelie G. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug;53(9):5095–101. Also available: http://dx​.doi.org/10.1167/iovs.12-9536. [PMC free article: PMC3416020] [PubMed: 22661464]
74.
Geruschat DR, Richards TP, Arditi A, et al. An analysis of observer-rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years. Clin Exp Optom. 2016 May;99(3):227–32. Also available: http://dx​.doi.org/10.1111/cxo.12359. [PMC free article: PMC5066820] [PubMed: 26804484]
75.
Garcia S, Petrini K, Rubin GS, et al. Visual and non-visual navigation in blind patients with a retinal prosthesis. PLoS ONE. 2015 Jul 30;10(7) Also available: http://dx​.doi.org/10​.1371/journal.pone.0134369. [PMC free article: PMC4520559] [PubMed: 26225762]
76.
da Cruz L, Dorn JD, Humayun MS, et al. Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial. Ophthalmology. 2016 Jul 19; Also available: http://dx​.doi.org/10​.1016/j.ophtha.2016.06.049. [PMC free article: PMC5035591] [PubMed: 27453256]
77.
Seider MI, Hahn P. Argus II retinal prosthesis malrotation and repositioning with intraoperative optical coherence tomography in a posterior staphyloma. Clin Ophthalmol. 2015;9:2213–6. Also available: http://dx​.doi.org/10.2147/OPTH.S96570. [PMC free article: PMC4664517] [PubMed: 26648688]
78.
Rizzo S, Belting C, Cinelli L, et al. The Argus II retinal prosthesis: 12-month outcomes from a single-study center. Am J Ophthalmol. 2014 Jun;157(6):1282–90. Also available: http://dx​.doi.org/10​.1016/j.ajo.2014.02.039. [PubMed: 24560994]
79.
Khan MA, Ho AC, Haller JA. Ten-year follow-up of a subretinal silicon prosthesis for retinitis pigmentosa. Ophthalmology. 2015 Oct 1;122(10) Also available: http://dx​.doi.org/10​.1016/j.ophtha.2015.07.031. [PubMed: 26398053]
80.
Chow AY, Bittner AK, Pardue MT. The artificial silicon retina in retinitis pigmentosa patients (an american ophthalmological association thesis). Trans Am Ophthalmol Soc. 2010 Dec;108:120–54. [PMC free article: PMC3016083] [PubMed: 21212852]
81.
Geruschat DR, Bittner AK, Dagnelie G. Orientation and mobility assessment in retinal prosthetic clinical trials. Optom Vis Sci. 2012 Sep;89(9):1308–15. [PMC free article: PMC3888774] [PubMed: 22902422]
82.
Klauke S, Goertz M, Rein S, et al. Stimulation with a wireless intraocular epiretinal implant elicits visual percepts in blind humans. Invest Ophthalmol Vis Sci. 2011 Jan;52(1):449–55. Also available: http://dx​.doi.org/10.1167/iovs.09-4410. [PubMed: 20861492]
83.
MenzelSevering J, Laube T, Brockmann C, et al. Implantation and explantation of an active epiretinal visual prosthesis: 2-year follow-up data from the EPIRET3 prospective clinical trial. Eye (Lond). 2012 Apr;26(4):502–9. Also available: http://dx​.doi.org/10.1038/eye.2012.35. [PMC free article: PMC3325584] [PubMed: 22422033]
84.
Roessler G, Laube T, Brockmann C, et al. Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial. Invest Ophthalmol Vis Sci. 2009;50(6):3003–8. Also available: http://dx​.doi.org/10.1167/iovs.08-2752. [PubMed: 19420330]
85.
Roessler G, Laube T, Brockmann C, et al. Angiographic findings following tack fixation of a wireless epiretinal retina implant device in blind RP patients. Graefes Arch Clin Exp Ophthalmol. 2011 Sep;249(9):1281–6. Also available: http://dx​.doi.org/10​.1007/s00417-011-1653-5. [PubMed: 21465287]
86.
Mokwa W, Goertz M, Koch C, et al. Intraocular epiretinal prosthesis to restore vision in blind humans. Conf Proc IEEE Eng Med Biol Soc. 2008;2008:5790–3. Also available: http://dx​.doi.org/10​.1109/IEMBS.2008.4650530. [PubMed: 19164033]
87.
Brandi A, Luu CD, Guymer RH, et al. Progress in the clinical development and utilization of vision prostheses: an update. Eye Brain. 2016 May 11;8:15–25. [PMC free article: PMC5398739] [PubMed: 28539798]
88.
Rizzo JF, Ayton LN. Psychophysical testing of visual prosthetic devices: a call to establish a multi-national joint task force. J Neural Eng. 2014 Apr;11(2):020301. Also available: http://dx​.doi.org/10​.1088/1741-2560/11/2/020301. [PubMed: 24556526]
89.
Bittner AK, Jeter P, Dagnelie G. Grating acuity and contrast tests for clinical trials of severe vision loss. Optom Vis Sci. 2011 Oct;88(10):1153–63. Also available: http://dx​.doi.org/10​.1097/OPX.0b013e3182271638. [PMC free article: PMC3183246] [PubMed: 21747309]
90.
Kiser AK, Mladenovich D, Eshraghi F, et al. Reliability and consistency of visual acuity and contrast sensitivity measures in advanced eye disease. Optom Vis Sci. 2005 Nov;82(11):946–54. [PubMed: 16317369]
91.
Kiser AK, Mladenovich D, Eshraghi F, et al. Reliability and consistency of dark-adapted psychophysical measures in advanced eye disease. Invest Ophthalmol Vis Sci. 2006 Jan;47(1):444–52. [PubMed: 16384995]
92.
McKnight PE, BabcockParziale J. Respondent impact on functional ability outcome measures in vision rehabilitation. Optom Vis Sci. 2007 Aug;84(8):721–8. [PubMed: 17700336]
93.
Babcock-Parziale J, McKnight PE, Head DN. Evaluating psychometric properties of a clinical and a self-report blind rehabilitation outcome measure. J Rehabil Res Dev. 2005 Jul-Aug;42(4):487–98. [PubMed: 16320144]
94.
Finger RP, McSweeney SC, Deverell L, et al. Developing an instrumental activities of daily living tool as part of the low vision assessment of daily activities protocol. Invest Ophthalmol Vis Sci. 2014 Dec;55(12):8458–66. Also available: http://dx​.doi.org/10.1167/iovs.14-14732. [PubMed: 25425306]
95.
Stelmack JA, Stelmack TR, Massof RW. Measuring low-vision rehabilitation outcomes with the NEI VFQ-25. Invest Ophthalmol Vis Sci. 2002 Sep;43(9):2859–68. [PubMed: 12202503]
96.
Finger RP, Tellis B, Crewe J, et al. Developing the impact of vision impairment-very low vision (IVI-VLV) questionnaire as part of the LoVADA protocol. Invest Ophthalmol Vis Sci. 2014 Oct;55(10):6150–8. Also available: http://dx​.doi.org/10.1167/iovs.14-14731. [PubMed: 25190656]
97.
Roman AJ, Cideciyan AV, Aleman TS, et al. Full-field stimulus testing (FST) to quantify visual perception in severely blind candidates for treatment trials. Physiol Meas. 2007 Jul 6;28(8) [PubMed: 17664667]
98.
Personal Communication. 2016. Public Commenter 3. 1 p.
99.
Jumper JM. FDA approves world's first artificial retina. Chicago (IL): American Society of Retina Specialists; 2013. [2015 Sep 04]. [internet] [13 p] Available: https://www​.asrs.org​/retina-times/details​/131/fda-approves-world-first-artificial-retina.
100.
Brosky J. Pixium Vision to challenge Second Sight with retinal implant. Med Dev Daily. 2015 Nov 13; Also available: https:​//medicaldevicedaily​.com/servlet/com​.accumedia.web.Dispatcher?next​=bioWorldHeadlines​_article&forceid=91347.
101.
Second Sight announces first successful implant of model of Orion I Visual Cortical Prosthesis. Sylmar (CA): Second Sight Medical Products, Inc; Apr 8, 2015. [internet] [3 p] Available: http://investors​.secondsight​.com/releasedetailcfm?releaseid​=905374.
102.
Personal Communication: patient comment. 2016. Public Commenter. 1 p.
103.
National Institute for Health and Care Excellence (NICE). Insertion of an epiretinal prosthesis for retinitis pigmentosa. London (UK): National Institute for Health and Care Excellence (NICE); 2015. Jun. 8 p. (Interventional procedure guidance; no.519) Also available: https://www​.nice.org.uk/guidance/ipg519.
104.
Vaidya A, Borgonovi E, Taylor RS, et al. The cost-effectiveness of the Argus II retinal prosthesis in retinitis pigmentosa patients. BMC Ophthalmol. 2014;14(1):49. Also available: http://dx​.doi.org/10​.1186/1471-2415-14-49. [PMC free article: PMC3990272] [PubMed: 24731533]
105.
Robinson KA, Saldanha IJ, Mckoy NA. Frameworks for determining research gaps during systematic reviews. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); Jun, 2011. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. HHSA 290-2007-10061-I.) AHRQ Publication No. 11-EHC043-EF. 79 p. (Methods future research needs report; no. 2). Also available: http://www​.effectivehealthcare​.ahrq.gov/ehc​/products/201/735​/FRN2_Frameworks_20110726.pdf. [PubMed: 21977524]