Safety and efficacy of subretinal visual implants in humans: Methodological aspects

Clinical and Experimental Optometry

Volumn 96, Issue 1, 2013, Pages 4-13

  Stingl, Katarina ^a   Bach, Michael ^b   Bartz Schmidt, Karl Ulrich ^a   Braun, Angelika ^c   Bruckmann, Anna ^a   Gekeler, Florian ^a   Greppmaier, Udo ^c   Hörtdörfer, Gernot ^d   Kusnyerik, Akos ^a,e   Peters, Tobias ^a   Wilhelm, Barbara ^a   Wilke, Robert ^a   Zrenner, Eberhart ^a  

^a UNIVERSITY OF TÜBINGEN   (Germany)

^b UNIVERSITY OF FREIBURG   (Germany)

^c Retina Implant AG   (Germany)

^d Mobility Training   (Germany)

^e SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

Artificial vision; Methodology; Neuroprosthetics; Retinitis pigmentosa; Safety and efficacy testing; Subretinal implant; Visual acuity

Indexed keywords

BLINDNESS; DAILY LIFE ACTIVITY; HUMAN; PATHOPHYSIOLOGY; PROSTHESIS; QUESTIONNAIRE; RETINA; REVIEW; VISUAL ACUITY; VISUAL PROSTHESIS;

ACTIVITIES OF DAILY LIVING; BLINDNESS; HUMANS; PROSTHESIS DESIGN; QUESTIONNAIRES; RETINA; VISUAL ACUITY; VISUAL PROSTHESIS;

EID: 84871937266     PISSN: 08164622     EISSN: 14440938     Source Type: Journal    
DOI: 10.1111/j.1444-0938.2012.00816.x     Document Type: Review

References (38)

1. Brelén ME, Vince V, Gérard B, Veraart C, Delbeke J. Measurement of evoked potentials after electrical stimulation of the human optic nerve. Invest Ophthalmol Vis Sci 2010; 51: 5351-5355.
2. Schmidt EM, Bak MJ, Hambrecht FT, Kufta CV, O'Rourke DK, Vallabhanath P. Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. Brain 1996;119: 507-522.
3. Zrenner E, Bartz-Schmidt KU, Benav H, Besch D, Bruckmann A, Gabel VP, Gekeler F etal. Subretinal electronic chips allow blind patients to read letters and combine them to words. Proc Biol Sci 2011; 278 (1711): 1489-1497.
4. Zrenner E. Will retinal implants restore vision? Science 2002; 295 (5557): 1022-1025
5. Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV etal. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology 2012; 119: 779-788.
6. Zrenner E. Artificial vision: Solar cells for the blind. Nature Photonics 2012; 6: 344-345.
7. Schwahn H, Gekeler F, Kohler K, Kobuch K, Sachs H, Schulmeyer F, Jakob W etal. Studies on the feasibility of a subretinal visual prosthesis: data from Yucatan micropig and rabbit. Graefes Arch Clin Exp Ophthalmol 2001; 239: 961-967.
8. Kohler K, Hartmann JA, Werts D, Zrenner E. [Histological studies of retinal degeneration and biocompatibility of subretinal implants]. Ophthalmologe 2001; 98: 364368.
9. Guenther E, Tröger B, Schlosshauer B, Zrenner E. Long-term survival of retinal cell cultures on retinal implant materials. Vision Res 1999; 39: 3988-3994.
10. Gekeler F, Szurman P, Grisanti S, Weiler U, Claus R, Greiner TO, Völher M etal. Compound subretinal prostheses with extra-ocular parts designed for human trials: successful long-term implantation in pigs. Graefes Arch Clin Exp Ophthalmol 2007; 245: 230-241.
11. Zrenner E, Bruckmann A, Greppmaier U, Hörtdörfer G, Kernstock C, Sliesoraityte I, Stingl K etal. Improvement of visual orientation and daily skills mediated by subretinal electronic implant Alpha IMS in previously blind RP patients. ARVO Meeting Abstracts 2011; 52: 457.
12. Stingl K, Bartz-Schmidt KU, Benav H, Besch D, Bruckmann A, Gekeler F, Greppmaier U etal. Subretinal electronic chips can restore useful visual functions in blind retinitis pigmentosa patients. Biomed Tech 2010; 55 (Suppl. 1):DOI 10.1515/BMT.2010.435.
13. Stingl K, Hörtdörfer G, Greppmaier U, Bruckmann A, Wilhelm B, Wrobel W, Sliesoraityte I etal. Vision mediated by the subretinal implant: improvement for activities of daily living-preliminary results. ARVO Meeting Abstracts 2011; 52: 456.
14. Stingl K, Bartz-Schmidt KU, Besch D, Gekeler F, Greppmaier U, Hörtdörfer G, Koitschev A etal. '[What can blind patients see in daily life with the subretinal Alpha IMS implant? Current overview from the clinical trial in Tübingen]', Ophthalmologe 2012; 109: 136-141.
15. Zrenner E, Bartz-Schmidt K, Gekeler F, Greppmaier U, Hipp S, Hörtdörfer G, Kernstock V etal. Seeing with subretinal electronic implants: study in ten patients with wireless implant Alpha-IMS. ARVO 2012 E-Abstract 6948.
16. Besch D, Sachs H, Szurman P, Gülicher D, Wilke R, Reinert S, Zrenner E etal. Extraocular surgery for implantation of an active subretinal visual prosthesis with external connections: feasibility and outcome in seven patients. Br J Ophthalmol 2008; 92: 1361-1368.
17. Sachs H, Bartz-Schmidt K-U, Gabel V-P, Zrenner E, Gekeler F. Subretinal implant: The intraocular implantation technique. Nova Acta Leopoldina NF III 2010; 379: 217-223.
18. Gekeler F, Zrenner E. [Status of the subretinal implant project. An overview]. Ophthalmologe 2005; 102: 941-949.
19. Stett A, Barth W, Weiss S, Haemmerle H, Zrenner E. Electrical multisite stimulation of the isolated chicken retina. Vision Res 2000; 40: 1785-1795.
20. Eckhorn R, Wilms M, Schanze T, Eger M, Hesse L, Eysel UT, Kisvárday ZF etal. Visual resolution with retinal implants estimated from recordings in cat visual cortex. Vision Res 2006; 46: 2675-2690.
21. Milam AH, Li ZY, Fariss RN. Histopathology of the human retina in retinitis pigmentosa. Prog Retin Eye Res 1998; 17: 175-205.
22. Santos A, Humayun MS, de Juan E, Greenburg RJ, Marsh MJ, Klock IB, Milam AH etal. Preservation of the inner retina in retinitis pigmentosa. A morphometric analysis. Arch Ophthalmol 1997; 115: 511-515.
23. Gekeler F, Messias A, Ottinger M, Bartz-Schmidt KU, Zrenner E. Phosphenes electrically evoked with DTL electrodes: a study in patients with retinitis pigmentosa, glaucoma and homonymous visual field loss and normal subjects. Invest Ophthalmol Vis Sci 2006; 47: 4966-4974.
24. de Balthasar C, Patel S, Roy A, Freda R, Greenwald S, Horsager A, Mahadevappa M etal. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci 2008; 49: 2303-2314.
25. Bruckmann A, Peters T, Mildenberger I, Wilke R, Naycheva L, Röck T, Messias A etal. Correlation of pupillary light responses with thresholds for electrically evoked phosphenes in patients blind from retintis pigmentosa. 2011. Available from: http://uak.medizin.uni-tuebingen.de/pupilcolloq/downloads/Sessions_and_Abstracts.pdf
26. Huang Q, Chowdhury V, Coroneo MT. Evaluation of patient suitability for a retinal prosthesis using structural and functional tests of inner retinal integrity. J Neural Eng 2009; 6: 035010.
27. Lahav M, Craft J, Albert DM, Ishii Y. Advanced pigmentary retinal degeneration: an ultrastructural study. Retina 1982; 2: 65-75.
28. Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Bartz-Schmidt KU, Sachs HG, Nemeth J etal. Results of the preoperative planning procedure before subretinal prosthesis implantation in humans. ARVO Meeting Abstracts 2010; 51: 3024.
29. Kübler-Ross E, Wessler S, Avioli LV. On death and dying. JAMA 1972; 221: 174-179.
30. Vance JC. A degree of vision. Lancet 2000; 356 (9240): 1517-1519.
31. Strougo Z, Badoux A, Duchanel D. [Psycho-affective problems associated with retinitis pigmentosa]. J Fr Ophtalmol 1997; 20: 111-116.
32. Wilke R, Bach M, Wilhelm B, Durst W, Trauzettel-Klosinski S, Zrenner E. Testing visual functions in patients with visual prostheses [Internet]. Artificial Sight. 2008. Available from: http://dx.doi.org/10.1007/978-0-387-49331-2_5
33. Bach M, Wilke M, Wilhelm B, Zrenner E, Wilke R. Basic quantitative assessment of visual performance in patients with very low vision. Invest Ophthalmol Vis Sci 2010; 51: 1255-1260.
34. Drover JR, Wyatt LM, Stager DR, Birch EE. The teller acuity cards are effective in detecting amblyopia. Optom Vis Sci 2009; 86: 755-759.
35. Bach M. The Freiburg Visual Acuity Test-variability unchanged by post-hoc re-analysis. Graefes Arch Clin Exp Ophthalmol 2007; 245: 965-971.
36. Lange C, Feltgen N, Junker B, Schulze-Bonsel K, Bach M. Resolving the clinical acuity categories 'hand motion' and 'counting fingers' using the Freiburg Visual Acuity Test (FrACT). Graefes Arch Clin Exp Ophthalmol 2009; 247: 137-142.
37. Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med 1983; 13: 595-605.
38. Peters T, Klingberg S, Oelman H, Kuttenkeuler C, Wilke R, Zabel T, Zrenner E etal. Changes of emotional state of blind patients in a pilot trial with a subretinal implant. Invest Ophthalmol Vis Sci (Abstracts) 2007; 48: 671.